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+TRANSACTIONS WITH RELATED PERSONS 
+During fiscal 2014, the Company leased certain office space from an entity controlled by Marco G. Calzavara, President and Managing Director, Meridian
+Bioscience Europe. Payments made under such arrangements during fiscal 2014 totaled approximately $200,000. 
+Nasdaq rules require the
+Company to conduct an appropriate review of related party transactions required to be disclosed by the Company pursuant to SEC Regulation S-K Item 404 for potential conflict of interest situations on an ongoing basis and that all such
+transactions must be approved by the Audit Committee or another Committee comprised of independent Directors. As a result, the Audit Committee annually reviews all such related party transactions and approves each related party transaction if it
+determines that it is in the best interests of the Company. Additionally, the Audit Committee’s Charter provides it the authority to review, approve and monitor transactions involving the Company and “related persons” (Directors and
+Executive Officers or their immediate family members, or shareholders owning five percent or greater of the Company’s outstanding stock). This also covers any related person transaction that meets the minimum threshold for disclosure in the
+proxy statement under the relevant SEC rules (generally, transactions involving amounts exceeding $120,000 in which a related person has a direct or indirect material interest). In considering the transaction, the Audit Committee may consider all
+relevant factors, including, as applicable, (i) the Company’s business rationale for entering into the transaction; (ii) the alternatives to entering into a related person transaction; (iii) whether the transaction is on terms
+comparable to those available to third parties, or in the case of employment relationships, to employees generally; (iv) the potential for the transaction to lead to an actual or apparent conflict of interest and any safeguards imposed to
+prevent such actual or apparent conflicts; and (v) the overall fairness of the transaction to the Company. This policy is included in the Company’s Employee Handbook. The approval of such related person transactions are evidenced by
+internal Company resolutions or memoranda.

raw/filings/0000794172/2015/0001193125-15-390041/filing_metadata.csv

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+cik,ticker,company_name,form,filing_date,report_date,acceptance_datetime,accession_number,primary_document,primary_doc_description,size,is_xbrl,is_inline_xbrl,document_url,filing_index_url,year,fiscal_year,is_primary_filing
+0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2015-11-30,2015-09-30,2015-11-30T14:04:07.000Z,0001193125-15-390041,d74026d10k.htm,ANNUAL REPORT,5028082,1,0,https://www.sec.gov/Archives/edgar/data/794172/000119312515390041/d74026d10k.htm,https://www.sec.gov/Archives/edgar/data/794172/000119312515390041/,2015,2015,1

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+ITEM 1. 
+BUSINESS 
+Overview 
+Meridian is a fully-integrated life science company with principal businesses in (i) the development, manufacture, sale and distribution of diagnostic
+test kits, primarily for certain gastrointestinal, viral, respiratory and parasitic infectious diseases; (ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch
+reagents used by researchers and other diagnostic manufacturers; and (iii) the contract development and manufacture of proteins and other biologicals under cGMP conditions for use by biopharmaceutical and biotechnology companies engaged in
+research for new drugs and vaccines. The Company was incorporated in Ohio in 1976. Our principal corporate offices are located near Cincinnati, Ohio, USA. 
+Our website is www.meridianbioscience.com . We make available our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form
+8-K and any amendments thereto, free of charge through this website, as soon as reasonably practicable after such material has been electronically filed with or furnished to the Securities and Exchange Commission (SEC). These reports may also be
+read and copied at the SEC’s public reference room at 100 F Street, N.E., Washington, DC 20549, phone number 1-800-732-0330. The SEC maintains an internet site containing these filings and other information regarding Meridian at
+www.sec.gov . The information on our website is not and should not be considered part of this Annual Report on Form 10-K. 
+- 5 - 
+Table of Contents 
+Reportable Segments 
+Our reportable segments are Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio. The Diagnostics segment consists of
+manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in the countries comprising North, Central and South America (the “Americas”); Europe, Middle East and Africa (“EMEA”); and other
+countries outside of the Americas and EMEA (rest of the world, or “ROW”). The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney,
+Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents domestically and abroad, including sales and business development offices in Singapore and Beijing, China
+to further pursue growing revenue opportunities in Asia. The Life Science segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and biotechnology companies
+engaged in research for new drugs and vaccines. Financial information for Meridian’s reportable segments is included in Note 7 to the consolidated financial statements. 
+Diagnostics Segment 
+Overview of Products and
+Markets 
+Our primary source of revenues continues to be diagnostic products, with our Diagnostics segment providing 75% of consolidated net
+revenues for fiscal 2015. Third-party revenues for this segment were $146,000, $142,000 and $145,000 for fiscal 2015, 2014 and 2013, respectively, reflecting a three-year compound annual growth rate of 4%. As of September 30, 2015, our
+Diagnostics segment had approximately 360 employees in seven countries. 
+Our diagnostic products provide accuracy, simplicity and speed; enable early
+diagnosis and treatment of common, acute medical conditions; and provide for better patient outcomes at reduced costs. We target diagnostics for disease states that (i) are acute conditions where rapid diagnosis impacts patient outcomes;
+(ii) have opportunistic demographic and disease profiles; (iii) are underserved by current diagnostic products; and (iv) have difficult sample handling requirements (stool, blood, urine and other body fluids). This approach has
+allowed us to establish significant market share in our target disease states. 
+Our diagnostic products span a broad menu of testing platforms and
+technologies, and also include transport media that store and preserve specimen samples from patient collection to laboratory testing. Our testing platforms include: 
+• 
+Isothermal DNA Amplification ( illumi gene ® brand ) – high sensitivity, molecular platform that is suitable for
+virtually any size laboratory, whether centralized or decentralized; provides flexibility to process from 1 to 10 tests per run in generally under one hour; and requires no batching of samples. 
+• 
+Rapid Immunoassay ( TRU ® , Immuno Card ® and
+Immuno Card STAT! ® brands) – single-use immunoassays that can be used in point-of-care settings; these tests have fast turnaround times
+(generally under 20 minutes); and can reduce expensive send-outs for hospitals and outpatient clinics. 
+- 6 - 
+Table of Contents 
+• 
+Enzyme-linked Immunoassay (Premier ® brand) – batch immunoassay platform that can process up to 96 tests per run; is highly
+accurate and economical; and is adaptable to automation. 
+Our diagnostic products are used principally in the detection of infectious
+diseases caused by various bacteria, viruses, parasites and pathogens. Our focus product families in Diagnostics are: 
+1. 
+C. difficile – causative agent for antibiotic-associated diarrhea from a hospital-acquired infection 
+2. 
+Foodborne – Enterohemorrhagic E. coli (EHEC) and Campylobacter jejuni (Campy) 
+3. 
+H. pylori – stomach ulcers 
+4. 
+Respiratory – Group A Streptococcus , M. pneumonia (Mycoplasma) and Bordetella pertussis , among tests for other diseases 
+5. 
+Women’s Health & Sexually Transmitted Diseases (“STD”) – Group B Streptococcus , Chlamydia trachomatis , Neisseria gonorrhea , Herpes Simplex Virus Type 1 & Type
+2 
+Revenues within these focus product families accounted for 79%, 77% and 77% of our Diagnostics segment’s third-party revenues during
+fiscal 2015, 2014 and 2013, respectively. These same product families accounted for 59%, 58% and 59% of consolidated net revenues in fiscal 2015, 2014 and 2013, respectively. 
+Our product portfolio includes over 140 diagnostic tests and transport media, and is marketed to acute care hospitals, reference laboratories and outpatient
+clinics in over 70 countries around the world. 
+We continue to invest in new product development for our molecular testing platform,
+illumi gene . This platform now has the following commercialized tests (assays): 
+1. 
+illumi gene ® C. difficile – commercialized in August 2010 
+2. 
+illumi gene ® Group B Streptococcus (Group B Strep or GBS) – commercialized in December 2011 
+3. 
+illumi gene ® Group A Streptococcus (Group A Strep) – commercialized in September 2012 
+4. 
+illumi gene ® Mycoplasma ( M. pneumonia; walking pneumonia) – commercialized in June 2013 
+5. 
+illumi gene ® Bordetella pertussis (whooping cough) – commercialized in March 2014 
+6. 
+illumi gene ® Chlamydia trachomatis – commercialized outside of U.S. in February 2015 
+7. 
+illumi gene ® Neisseria gonorrhea – commercialized outside of U.S. in February 2015 
+8. 
+illumi gene ® HSV 1&2 (Herpes Simplex Virus Type 1 & Type 2) – commercialized outside of U.S. in May 2015; commercialized in U.S.
+in July 2015 
+We have several additional illumi gene tests in development, including
+bloodborne pathogens that are the causative agents for malaria. We have a robust pipeline of illumi gene opportunities and continue to add new assays to our illumi gene platform
+menu. 
+- 7 - 
+Table of Contents 
+We believe that our illumi gene system has been well-accepted in
+our global markets. We now have approximately 1,465 customer account placements. Of these account placements, approximately 1,300 accounts have completed evaluations and validations and are regularly purchasing product, with the balance of our
+account placements being in some stage of product evaluation and/or validation. Of our account placements, we have over 400 accounts that are regularly purchasing, evaluating and/or validating two or more assays. 
+Market Trends 
+The global market for infectious
+disease tests continues to expand as new disease states are identified, new therapies become available, and worldwide standards of living and access to health care improve. More importantly, within this market, there is a continuing shift from
+conventional testing, which requires highly trained personnel and lengthy turnaround times for test results, to more technologically advanced testing, which can be performed by less highly trained personnel and completed in minutes or hours. 
+The increasing global pressures to contain total health care costs have accelerated the increased use of diagnostic testing. With rapid and accurate
+diagnoses of infectious diseases, physicians can pinpoint appropriate therapies quickly, leading to faster recovery, shorter hospital stays and lower overall treatment cost. The creation of Accountable Care Organizations (ACOs) in our U.S. market,
+in particular, has the goal of increasing the efficiency of health care delivery, reducing spending and improving clinical outcomes. We believe our product portfolio positions us competitively with ACOs and health care systems that are transitioning
+from fee-for-service compensation models, to compensation models based on the total outcome costs of a given patient. Our C. difficile , Group B Streptococcus , Group A Streptococcus , and H. pylori products are all examples
+of how a highly accurate diagnostic test on the front end can mitigate or reduce down-stream costs for antibiotic use, symptom-relieving drugs and hospital stays. 
+We also continue to see aggregation of buying power in our U.S. market via multi-hospital group purchasing organizations and integrated delivery networks,
+consolidation among reference laboratories, and acquisition of physician practices by hospitals. We utilize multi-year supply agreements to secure our business where possible and appropriate. 
+Cost containment pressures have also affected health care systems outside the U.S., particularly in Europe, where the health care systems are generally
+government-run. The level of government budget deficits can have an adverse effect on the amount of government health care spend. 
+Sales, Marketing
+and Focus Product Families 
+Our Diagnostics segment’s sales and distribution network consists of the following for each of the broad
+geographic regions we serve: 
+- 8 - 
+Table of Contents 
+North America 
+In North America, our sales and distribution network consists of a direct sales force (U.S. only) complemented by independent distributors. The
+use of independent distributors in the U.S. allows our products to reach any size health care facility and also provides our customers the option to purchase our products directly from Meridian or through an authorized distributor. Two independent
+distributors in the U.S. accounted for 10% or more of consolidated net revenues in fiscal 2015, 2014 and 2013: Cardinal Healthcare Corporation and Thermo Fisher Scientific. Our revenues from Cardinal were approximately $29,000, $28,000 and $35,000
+during fiscal 2015, 2014 and 2013, respectively. Our revenues from Thermo Fisher were approximately $25,000, $23,000 and $25,000 during fiscal 2015, 2014 and 2013, respectively. 
+EMEA 
+In EMEA, our sales
+and distribution network consists of direct sales forces in Belgium, France, Holland and Italy, and independent distributors in other European countries, Africa and the Middle East. We have implemented a direct sales presence in Germany and the U.K.
+for our illumi gene products, and utilize independent distributors for our immunoassay products. We maintain a distribution center near Milan, Italy. 
+ROW 
+With the exception
+of Australia, in which we utilize a direct sales force, we utilize independent distributors throughout the ROW. 
+Our Diagnostics segment’s focus
+product families are described below: 
+C. difficile 
+C. difficile , causative agent of serious hospital acquired bacterial infections, is our largest product family, generating approximately $31,000 in
+global revenues for fiscal 2015, a 12% decrease from fiscal 2014 – reflecting a combination of sales of our molecular-based and traditional immunoassay products, with our molecular product now representing approximately 80% of this product
+category. This product family has experienced significant competition in recent years from new technologies, primarily other molecular testing platforms. See Competition discussion below. 
+Foodborne 
+Our foodborne product family achieved
+approximately $25,000 in global revenues for fiscal 2015, an increase of 8%, with over 95% of such sales occurring in the U.S. Our foodborne products include tests for Enterohemorrhagic E. coli (EHEC) and Campylobacter jejuni (Campy).
+In the U.S. market, we believe that there are potentially 20 million stool cultures that are tested annually for foodborne illnesses. We believe that we have less than a 20% market share for EHEC and less than a 5% market share for Campy. 
+- 9 - 
+Table of Contents 
+We are continuing to re-emphasize the benefits of increased sensitivity and faster turnaround time versus culture
+methods in our marketing programs. The primary competition for our foodborne products is laboratory culture methods and an immunoassay EHEC shiga toxin test from one of our competitors. We believe that our test offers better workflow, less hands-on
+time and quicker results, in addition to being fully compliant with CDC-recommended testing methods. 
+Helicobacter pylori 
+H. pylori , a bacterium found in the stomach, is a major cause of peptic ulcers and is linked to duodenal ulcers and stomach cancer. H. pylori 
+represents our second largest product family, generating approximately $30,000 in global revenues for 2015, or 6% growth. We offer both antibody and direct antigen tests in alternative formats (single-use and high volume batch). Our major
+competition in this product family is alternative test methods, serology and urea breath, and the prescription of symptom-relieving medications. Over 75% of our H. pylori product sales are in the U.S., where our strategy for this product line
+has been to partner with managed care companies to promote the health and economic benefits of a test and treat strategy, and to move physician behavior away from serology-based testing toward direct antigen testing. In the U.S. market, we believe
+that there are potentially 30 million people suffering from peptic ulcers and we believe that we currently have an approximate 5% market share. 
+The patents for our H. pylori products are owned by us and expire in May 2016 in the U.S. and in 2017 in countries outside the U.S. We expect
+competition with respect to our H. pylori products to increase upon the expiration of these patents in 2016 and 2017 as we currently market the only FDA-cleared test to detect H. pylori antigen in stool samples. Such competition may
+have an adverse impact on our selling prices for these products, or our ability to retain business at prices acceptable to us, and consequently, adversely affect our future results of operations and liquidity, including revenues and gross profit. In
+order to mitigate any loss in revenues upon patent expiration, among other things, we are researching and experimenting with new products (e.g., detection of H. pylori on molecular platforms) and attempting to secure significant customers
+under long-term contracts. We are unable to provide any assurances that we will be successful with any mitigation strategy or that any mitigation strategy will prevent an adverse effect on our future results of operations and liquidity, including
+revenues and gross profit. 
+Respiratory 
+In addition to our immunoassay tests to detect influenza, which have been part of our product portfolio for a number of years, during the last
+three years we have also introduced three molecular-based products on our illumi gene platform to detect various respiratory conditions. These molecular products, which are less seasonally-dependent than our
+influenza products, include illumi gene Group A Strep (2012), illumi gene Mycoplasma (2013) and illumi gene Pertussis (2014). Since their
+commercialization, these products have been widely accepted in the marketplace and during fiscal 2015 grew to represent over 40% of our total Respiratory product family revenues of $22,000. 
+- 10 - 
+Table of Contents 
+Women’s Health & STD 
+In December 2011, we introduced our illumi gene Group B Strep product to detect Group B Streptococcus (GBS) in
+expectant mothers. Early detection of GBS, a major perinatal pathogen for both mothers and their infants that is associated with significant morbidity and mortality, is critical to the prevention and treatment of serious disease in infants. During
+fiscal 2015, we expanded our illumi gene molecular product platform to include three additional tests directly related to women’s health; these include tests for Chlamydia trachomatis (Chlamydia), Neisseria
+gonorrhea (Gonorrhea) and Herpes Simplex Virus Type 1 & Type 2. With the GBS and HSV tests available worldwide, and the Chlamydia and Gonorrhea tests currently commercialized only outside the U.S., revenues from these women’s
+health & STD products grew to over $7,000 during 2015, and are currently expected to exceed $10,000 in fiscal 2016. 
+Competition
+Our major competitors in molecular diagnostics are Cepheid and Becton Dickinson, who have systems with multiple-assay menus. We also face
+competition in molecular diagnostics, but to a lesser degree, from companies such as Alere, Great Basin, Nanosphere and Quidel. These latter companies have a limited commercial menu and tend to compete strictly on price. We believe that our
+molecular platform offers a number of competitive features: 
+• 
+Molecular assay sensitivity that is comparable to higher costing PCR; 
+• 
+Low capital investment with no instrument service cost; 
+• 
+Small footprint that is portable and does not consume much laboratory space; and 
+• 
+Product menu that fits with initiatives to improve clinical and economic outcomes. 
+Our major competitors in
+rapid immunoassay diagnostics are primarily Alere and Quidel. These companies tend to compete strictly on price. We believe that with the breadth and depth of our product portfolio, we are well positioned to capitalize on the migration to molecular
+testing. 
+Research and Development 
+Our
+Diagnostics segment’s research and development organization, which is located at our corporate headquarters in Newtown, Ohio, a suburb of Cincinnati, has expertise in biochemistry, immunology, mycology, bacteriology, virology, parasitology and
+molecular biology. Research and development expenses for the Diagnostics segment for fiscal 2015, 2014 and 2013 were approximately $10,000, $10,000 and $8,000, respectively. This research and development organization focuses its activities on new
+product and new technology development, new applications for our existing technologies, and improvements to existing products. Research and development efforts may occur in-house or with collaborative partners. We believe that new product
+development is a key source for sustaining revenue growth. The products within our illumi gene molecular platform and H. pylori product family were developed solely in-house. 
+- 11 - 
+Table of Contents 
+Manufacturing 
+Our immunoassay and molecular products require the production of highly specific and sensitive antigens, antibodies, primers and enzymes. While
+we produce substantially all of our own requirements including monoclonal and polyclonal antibodies, and a variety of fungal, bacterial and viral antigens, currently a number of the raw materials used in our products, including our
+illumi gene molecular products, are purchased from outside vendors. With the recent expansion of our molecular diagnostic manufacturing capacity at our Cincinnati, Ohio location, we brought in-house certain
+molecular component manufacturing that was previously outsourced. We believe that we have sufficient manufacturing and sourcing capacity for anticipated growth over the next several years. 
+Intellectual Property, Patents and Licenses 
+We
+own or license U.S. and foreign patents, most of which are for products manufactured by our Diagnostics segment. These patents are used in our manufacturing processes for selected products (method patents) or may relate to the design of the test
+device technology format (design patents). In the absence of patent protection, we may be vulnerable to competitors who successfully replicate our production and manufacturing technologies and processes. Our employees are required to sign
+confidentiality and non-disclosure agreements designed to protect our proprietary products. Revenues from these products in fiscal 2015 and fiscal 2014 were as follows: 
+Product/Technology Family 
+Number of 
+products 
+% of fiscal year 
+consolidated revenues 
+2015 
+2014 
+illumi gene 
+8 
+21 
+% 
+20 
+% 
+H. pylori 
+2 
+14 
+% 
+14 
+% 
+Respiratory immunoassay 
+4 
+2 
+% 
+2 
+% 
+Other 
+5 
+1 
+% 
+1 
+% 
+Total patented products 
+19 
+38 
+% 
+37 
+% 
+The patents for the illumi gene products are licensed from a third party under
+a non-exclusive license agreement and expire between 2020 and 2022. These patents were issued in the U.S., European Community and other countries. The term of our license agreement runs until the last patent expires in 2022, at which point we will
+be free to practice the patents without any restriction or royalty obligation. 
+The patents for our H. pylori products are
+owned by us and expire in May 2016 in the U.S. and in 2017 outside the U.S. (principally, Australia, Canada, European Community and Japan). We expect competition with respect to our H. pylori products to increase upon the expiration of these
+patents in 2016 and 2017 as we currently market the only FDA-cleared test to detect H. pylori antigen in stool samples. Such competition may have an adverse impact on our selling prices for these products or our ability to retain business at
+prices acceptable to us, and consequently, adversely affect our future results of operations and liquidity, including revenues and gross profit. In order to mitigate any loss in revenues upon patent expiration, we are researching and experimenting
+with new products (e.g., detection of H. pylori in samples other than stool and detection of H. pylori on molecular platforms). We are unable to provide any assurances that we will be successful with any mitigation strategy or that any
+mitigation strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and gross profit. 
+- 12 - 
+Table of Contents 
+The patents for our immunoassay respiratory products are owned by us and expire in 2022 (two products) and 2027
+(one product). These patents were issued in the U.S. and European Community, among other jurisdictions. 
+The remaining five patented products are spread
+over multiple product families. These patents are either owned by us, or we are free to practice the patents without any restriction or royalty obligation. These patents, where still in effect, collectively expire between 2016 and 2027. 
+Government Regulation 
+Our diagnostic products are
+regulated by the Food & Drug Administration (FDA) as “devices” pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of three classes (i.e., Class I, II or III). Class
+I and II devices are not expressly approved by the FDA, but, instead, are “cleared” for marketing. Class III devices generally must receive “pre-market approval” from the FDA as to safety and effectiveness. 
+Each of the diagnostic products currently marketed by us in the United States has been cleared by the FDA pursuant to the 510(k) clearance process or is
+exempt from such requirements. We believe that most, but not all, products under development will be classified as Class I or II medical devices and, in the case of most of our Class I and all Class II devices, will be eligible for 510(k) clearance;
+however, we can make no assurances in this regard. Meridian’s TRU FLU ® rapid influenza assay was cleared in 2006 as a Class I device. In May 2014, the FDA proposed reclassifying
+rapid influenza assays as a Class II device, requiring the submission of a new 510(k) application and subjecting TRU FLU and similar competitive devices to increased requirements for sensitivity. If the proposed rule becomes effective, Meridian
+will have one year to bring its assay up to the new requirements or remove it from the market. Sales of the TRU FLU product totaled approximately $2,000 in fiscal 2015. 
+Sales of our diagnostic products in foreign countries are subject to foreign government regulation, largely similar to that of the FDA. 
+Meridian’s Cincinnati manufacturing facility is certified to ISO 13485:2012. 
+- 13 - 
+Table of Contents 
+Medical Device Tax 
+On January 1, 2013, the medical device tax established as part of the U.S. health care reform legislation became effective and as a result, the Company
+made its first required tax deposit near the end of January 2013. During fiscal 2015, 2014 and 2013, the Company recorded to cost of sales approximately $1,900, $1,750 and $1,300, respectively, of medical device tax expense related to this
+legislation. 
+Seasonal Factors and Sporadic Outbreaks 
+Our principal business is the sale of a broad range of diagnostic test kits for common gastrointestinal, viral, upper respiratory and parasitic infectious
+diseases. Certain infectious diseases may be seasonal in nature, while others may be associated with sporadic outbreaks, such as foodborne illnesses, or pandemics such as the H1N1 influenza outbreak during fiscal 2009. While we believe that the
+breadth of our diagnostic product lines reduces the risk that infections subject to seasonality and sporadic outbreaks will cause significant variability in diagnostic revenues, we can make no assurance that revenues will not be impacted period over
+period by such factors. 
+Life Science Segment 
+Overview of Products and Markets 
+Our Life Science
+segment’s business focuses on the development, manufacture, sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturing
+companies, as well as contract development and manufacturing services under clinical cGMP conditions. Third-party revenues for this segment were approximately $49,000, $47,000 and $44,000 for fiscal 2015, 2014 and 2013, respectively. As of
+September 30, 2015, our Life Science segment had approximately 220 employees in seven countries. 
+Most of the revenues for our Life Science segment
+currently come from the manufacture, sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturing companies focused on the
+development of immunoassay and molecular tests. Approximately 65% of Life Science revenues are generated from the industrial market, defined as diagnostic manufacturers and the agriculture industry. This is an increasing focus of our Bioline
+molecular component business, which historically focused on the academic/research market that comprises the remaining 35% of Life Science revenues. We utilize direct sales teams in key countries such as the U.S., the U.K., Germany, France, Australia
+and Singapore. Opened in 2013, the Singapore sales and business development office is designed to increase our presence and our revenue opportunities in Asia for both molecular and immunoassay components. Additionally, in order to further pursue
+revenue opportunities in Asia, and China in particular, during fiscal 2015 we opened a representative office in Beijing, China. We utilize a network of distributors in other major countries. During fiscal 2015, 16% of third-party revenues for this
+segment were from two diagnostic manufacturing customers. 
+- 14 - 
+Table of Contents 
+Products such as antibodies, antigens and reagents are marketed primarily to diagnostic manufacturing customers
+as a source of raw materials for their immunoassay products, or as an outsourced step in their manufacturing processes. For example, we supply a number of major diagnostic manufacturers with proteins used to detect hepatitis A and rubella. These
+products are typically sold in bulk quantities, and may also be custom-designed for a particular manufacturer’s requirements. Sales efforts are focused on multi-year supply arrangements in order to provide stability in volumes and pricing. We
+believe this benefits both us and our customers. 
+Molecular biology products such as PCR/qPCR reagents, nucleotides and competent cells are marketed to
+academic/research and industrial customers. These products are used in measuring DNA and RNA in clinical and agricultural applications. These reagents improve the purity, yield and speed of PCR reactions. Products such as MyTaq™ and
+SensiFAST™ are examples of this type of PCR/qPCR reagent. 
+Our clinical cGMP protein production facility in Memphis, Tennessee serves as an enabling
+technology for process development and large-scale manufacturing for biologicals used in new drugs and vaccines. The size of the facility is intended to accommodate manufacturing requirements for Phase I and Phase II clinical trials for
+biopharmaceutical, biotechnology and government agency customers. Our revenues for contract services were approximately $3,000 in each of fiscal 2015, 2014 and 2013. 
+Market Trends 
+Globally, sales of molecular
+components are growing at a faster pace than immunoassay components, and this is consistent with our business in constant-currency. Geographic expansion is a significant strategy for our Life Science segment, along with further penetration into
+industrial markets with our molecular products. 
+Competition 
+The market for bulk biomedical reagents is highly competitive. Important competitive factors include product quality, price, customer service, and reputation.
+We face competitors, many of which have greater financial, research and development, sales and marketing, and manufacturing resources, and where sole-source supply arrangements do not exist. Customers also may choose to manufacture their biomedical
+reagents in-house rather than purchase from outside vendors such as Meridian. 
+The academic/research market is highly fragmented. Individual purchases are
+typically of small quantities. The breadth of product offerings, quality, price and service, including on-line capabilities and technical resources, are important factors to building customer loyalty and repeat purchases. 
+The market for contract manufacturing in a validated cGMP facility, such as our Memphis facility, is also competitive. Important competitive factors include
+reputation, customer service and price. Although the product application for this facility was built from our existing expertise in cell culture manufacturing techniques, we face competitors with greater experience in contract manufacturing in a
+clinical cGMP environment. 
+- 15 - 
+Table of Contents 
+Research and Development 
+Research and development expenses for our Life Science segment for each of fiscal 2015, 2014 and 2013 were approximately $3,000. This research and development
+organization is involved in activities for our cGMP facility and development of new molecular reagent products. 
+Manufacturing and Government
+Regulation 
+Our Life Science facilities are ISO 9001:2008 certified, and where appropriate, comply with Regulation EC 1069:2009. 
+The cGMP clinical grade proteins that are produced in our Memphis facility are intended to be used as “injectibles,” and, as such, they are produced
+under cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA. Following clinical trials, approval and licensing of these products is the responsibility of the applicant, who owns the rights to each protein. Typically, the
+customer is the applicant, not Meridian Life Science. 
+Acquisitions 
+Acquisitions have played an important role in the growth of our businesses. Our acquisition objectives include, among other things: (i) enhancing product
+offerings; (ii) improving product distribution capabilities; (iii) providing access to new markets; and/or (iv) providing access to key biologicals or new technologies that lead to new products. Although we cannot provide any
+assurance that we will consummate any additional acquisitions in the future, nor can we provide any assurance that any acquisitions will accomplish these objectives, we expect that the potential for acquisitions will continue to provide
+opportunities for revenue and earnings growth in the future. 
+During November 2015, we made a minority investment in Oasis Diagnostics ® Corporation in order to evaluate our interest in saliva diagnostics and collection devices. Oasis is located in Vancouver, Washington. 
+International Markets 
+International markets are an
+important source of revenues and future growth opportunities for both of our segments. For both segments combined, revenues from customers located outside of North America approximated $49,000 or 25% of consolidated fiscal 2015 revenues, $55,000 or
+29% of consolidated fiscal 2014 revenues, and $54,000 or 29% of consolidated fiscal 2013 revenues. We expect to continue to look to international markets as a source of new revenues and growth in the future. 
+- 16 - 
+Table of Contents 
+During fiscal 2015, currency exchange had an approximate $4,700 unfavorable impact on revenues; $3,200 within the
+Diagnostics segment and $1,500 within the Life Science segment. This compares to currency exchange rates having an approximate $850 favorable impact on revenues in fiscal 2014; $600 favorable within the Diagnostics segment and $250 within the Life
+Science segment. Due to natural hedge relationships with expenses, both cost of sales and operating expenses, the overall impact of exchange rate fluctuations on net earnings was not material during fiscal 2015, 2014 or 2013. 
+Environmental 
+We are a conditionally exempt, small
+quantity generator of hazardous waste and have a U.S. EPA identification number. We are in compliance with applicable portions of the federal and state hazardous waste regulations and have never been a party to any environmental proceeding.

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+Item 13 
+Certain Relationships and Related Transactions, and Director Independence 
+76

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+ITEM 9A. 
+CONTROLS AND PROCEDURES 
+As of
+September 30, 2015, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our
+disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure
+controls and procedures were effective as of September 30, 2015. There have been no changes in our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the fourth fiscal
+quarter that has materially affected, or is reasonably likely to affect, our internal control over financial reporting, or in other factors that could significantly affect internal control subsequent to September 30, 2015. 
+Our internal control report is included in this Annual Report on Form 10-K after Item 8, under the caption “Management’s Report on Internal
+Control over Financial Reporting.”

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+TRANSACTIONS WITH RELATED PERSONS 
+During fiscal 2016, the Company leased certain office space from an entity controlled by Marco G. Calzavara, President and Managing Director, Meridian
+Bioscience Europe. Payments made under such arrangements during fiscal 2016 totaled approximately $170,000. 
+Nasdaq rules require the
+Company to conduct an appropriate review of related party transactions required to be disclosed by the Company pursuant to SEC Regulation S-K Item 404 for potential conflict of interest situations on an ongoing basis and that all such transactions
+must be approved by the Audit Committee or another Committee comprised of independent Directors. As a result, the Audit Committee annually reviews all such related party transactions and approves each related party transaction if it determines
+that it is in the best interests of the Company. Additionally, the Audit Committee’s Charter provides it the authority to review, approve and monitor transactions involving the Company and “related persons” (Directors and
+Executive Officers or their immediate family members, or shareholders owning five percent or greater of the Company’s outstanding stock). This also covers any related person transaction that meets the minimum threshold for disclosure in
+the proxy statement under the relevant SEC rules (generally, transactions involving amounts exceeding $120,000 in which a related person has a direct or indirect material interest). In considering the transaction, the Audit Committee may
+consider all relevant factors, including, as applicable: (i) the Company’s business rationale for entering into the transaction; (ii) the alternatives to entering into a related person transaction; (iii) whether the transaction is on terms
+comparable to those available to third parties, or in the case of employment relationships, to employees generally; (iv) the potential for the transaction to lead to an actual or apparent conflict of interest and any safeguards imposed to prevent
+such actual or apparent conflicts; and (v) the overall fairness of the transaction to the Company. This policy is included in the Company’s Employee Handbook. The approval of such related person transactions are evidenced by internal
+Company resolutions or memoranda.

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+0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2016-11-29,2016-09-30,2016-11-29T18:24:05.000Z,0001193125-16-779250,d270799d10k.htm,ANNUAL REPORT,6692834,1,0,https://www.sec.gov/Archives/edgar/data/794172/000119312516779250/d270799d10k.htm,https://www.sec.gov/Archives/edgar/data/794172/000119312516779250/,2016,2016,1

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+ITEM 1. 
+BUSINESS 
+Overview 
+Meridian is a fully-integrated life science
+company with principal businesses in (i) the development, manufacture, sale and distribution of diagnostic test kits, primarily for certain gastrointestinal, viral, respiratory, and parasitic infectious diseases, and elevated blood lead levels; and
+(ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells, and bioresearch reagents used by researchers and other diagnostic manufacturers. The Company was incorporated in Ohio in
+1976. Our principal corporate offices are located near Cincinnati, Ohio, USA. 
+During March 2016, we acquired all of the outstanding common stock of
+Magellan Biosciences, Inc., and its wholly-owned subsidiary Magellan Diagnostics, Inc. (collectively, “Magellan”), which is now reported as part of our Diagnostics operating segment. Headquartered near Boston, Massachusetts, Magellan
+is a leading manufacturer of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care lead testing systems in the U.S. 
+- 5 - 
+Table of Contents 
+Our website is www.meridianbioscience.com . We make available our Annual Reports on Form 10-K,
+Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments thereto, free of charge through this website, as soon as reasonably practicable after such material has been electronically filed with or furnished to the Securities and
+Exchange Commission (SEC). These reports may also be read and copied at the SEC’s public reference room at 100 F Street, N.E., Washington, DC 20549, phone number 1-800-732-0330. The SEC maintains an internet site containing these
+filings and other information regarding Meridian at www.sec.gov . The information on our website is not and should not be considered part of this Annual Report on Form 10-K. 
+Reportable Segments 
+Our reportable segments are
+Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio, which also serves as the Diagnostics segment’s base of manufacturing operations and research and development for infectious disease products. The
+Diagnostics segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits in the countries comprising North, Central and South America (the “Americas”); Europe, Middle East and
+Africa (“EMEA”); and other countries outside of the Americas and EMEA (rest of the world, or “ROW”). As previously noted, the Diagnostics segment includes the Company’s recent acquisition of Magellan, which is located
+in Billerica, Massachusetts (near Boston). Its facility includes research, development, manufacturing, marketing, sales, and distribution operations. The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca
+Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells, and bioresearch reagents domestically and abroad, including
+sales and business development offices in Singapore and Beijing, China to further pursue growing revenue opportunities in Asia. Financial information for Meridian’s reportable segments is included in Note 8 to the consolidated financial
+statements. 
+Diagnostics Segment 
+Overview of
+Products and Markets 
+Our primary source of revenues continues to be diagnostic products, with our Diagnostics segment providing 74% of
+consolidated net revenues for fiscal 2016. Third-party revenues for this segment were $145,000, $146,000 and $142,000 for fiscal 2016, 2015 and 2014, respectively. As of September 30, 2016, our Diagnostics segment had approximately 440
+employees in seven countries. 
+Our diagnostic products provide accuracy, simplicity and speed; enable early diagnosis and treatment of common, acute
+medical conditions; and provide for better patient outcomes at reduced costs. We target diagnostics for disease states that (i) are conditions where rapid diagnosis impacts patient outcomes; (ii) have opportunistic demographic and disease
+profiles; (iii) are underserved by current diagnostic products; and (iv) have difficult sample handling requirements (stool, blood, urine and other body fluids). This approach has allowed us to establish significant market share in our target
+disease states. 
+- 6 - 
+Table of Contents 
+Our diagnostic products span a broad menu of testing platforms and technologies, and also include transport media
+that store and preserve specimen samples from patient collection to laboratory testing. Our testing platforms include: 
+• 
+Isothermal DNA Amplification ( illumi gene brand) – high sensitivity, molecular platform that is suitable for virtually any size laboratory, whether centralized or decentralized;
+provides flexibility to process from 1 to 10 tests per run in generally under one hour; and requires no batching of samples. 
+• 
+Rapid Immunoassay (TRU, Immuno Card and Immuno Card STAT! brands) – single-use immunoassays that can be used in point-of-care settings; have fast turnaround
+times (generally under 20 minutes); and can reduce expensive send-outs for hospitals and outpatient clinics. 
+• 
+Enzyme-linked Immunoassay (PREMIER brand) – batch immunoassay platform that can process up to 96 tests per run; is highly accurate and economical; and is adaptable to automation. 
+• 
+Anodic Stripping Voltammetry (LeadCare brand) – electrical chemical sensor platform for quantitative determination of lead levels in blood. 
+Our diagnostic products are used principally in the detection of infectious diseases caused by various bacteria, viruses, parasites and pathogens, including
+most notably the following general areas: 
+• 
+C. difficile – causative agent for antibiotic-associated diarrhea from a hospital-acquired infection 
+• 
+Foodborne – Enterohemorrhagic E. coli (EHEC) and Campylobacter jejuni (Campy) 
+• 
+H. pylori – stomach ulcers 
+• 
+Respiratory – Group A Streptococcus , M. pneumoniae (Mycoplasma) and Bordetella pertussis , among tests for other diseases 
+• 
+Women’s Health & Sexually Transmitted Diseases (“STD”) – Group B Streptococcus , Chlamydia trachomatis , Neisseria gonorrhea , Herpes Simplex Virus Type 1 & Type 2
+Our diagnostics products also include Magellan’s LeadCare brand of tests for quantitative determination of blood lead levels. 
+Our product portfolio includes over 140 diagnostic tests and transport media, and is marketed to acute care hospitals, reference laboratories, outpatient
+clinics and physician office laboratories in over 70 countries around the world. 
+- 7 - 
+Table of Contents 
+We continue to invest in new product development for our molecular testing platform,
+illumi gene . This platform now has the following commercialized tests (assays): 
+1. 
+illumi gene C. difficile – commercialized in August 2010 
+2. 
+illumi gene Group B Streptococcus (Group B Strep or GBS) – commercialized in December 2011 
+3. 
+illumi gene Group A Streptococcus (Group A Strep) – commercialized in September 2012 
+4. 
+illumi gene Mycoplasma ( M. pneumoniae; walking pneumonia) – commercialized in June 2013 
+5. 
+illumi gene Bordetella pertussis (whooping cough) – commercialized in March 2014 
+6. 
+illumi gene Chlamydia trachomatis – commercialized outside of U.S. in February 2015 
+7. 
+illumi gene Neisseria gonorrhea – commercialized outside of U.S. in February 2015 
+8. 
+illumi gene HSV 1&2 (Herpes Simplex Virus Type 1 & Type 2) – commercialized in July 2015 
+9. 
+illumi gene Malaria – commercialized outside of U.S. in February 2016 
+10. 
+illumi gene Mycoplasma Direct ( M. pneumoniae; walking pneumonia) – commercialized in June 2016 
+We have several additional illumi gene tests in development, a robust pipeline of illumi gene opportunities and a plan
+to continue adding new assays to our illumi gene platform menu. 
+We believe that our illumi gene system has been
+well-accepted in our global markets. We now have over 1,500 customer account placements. Of these account placements, approximately 1,300 accounts have completed evaluations and validations and are regularly purchasing product, with the
+balance of our account placements being in some stage of product evaluation and/or validation. Of our account placements, we have nearly 450 accounts that are regularly purchasing, evaluating and/or validating two or more assays. 
+Market Trends 
+The global market for infectious
+disease tests continues to expand as new disease states are identified, new therapies become available, and worldwide standards of living and access to health care improve. More importantly, within this market, there is a continuing shift from
+conventional testing, which requires highly trained personnel and lengthy turnaround times for test results, to more technologically advanced testing, which can be performed by less highly trained personnel and completed in minutes or hours. 
+The increasing global pressures to contain total health care costs have accelerated the increased use of diagnostic testing. With rapid and accurate
+diagnoses of infectious diseases, physicians can pinpoint appropriate therapies quickly, leading to faster recovery, shorter hospital stays and lower overall treatment cost. Integrated Delivery Networks (IDNs) and Accountable Care Organizations
+(ACOs) in our U.S. market have the goal of increasing the efficiency of health care delivery, reducing spending and improving clinical outcomes. We believe our product portfolio positions us competitively with IDNs, ACOs and health care systems that
+are transitioning from fee-for-service compensation models, to value based reimbursement. Our C. difficile , Group B Streptococcus , Group A Streptococcus and H. pylori products are all examples of how a highly accurate
+diagnostic test on the front end can mitigate or reduce down-stream costs for antibiotic use, symptom-relieving drugs and hospital stays. 
+- 8 - 
+Table of Contents 
+We also continue to see aggregation of buying power in our U.S. market via multi-hospital group purchasing
+organizations and integrated delivery networks, consolidation among reference laboratories, and acquisition of physician practices by hospitals, health systems, and for-profit specialty health care companies. We utilize multi-year supply agreements
+to secure our business where we deem appropriate. 
+Cost containment pressures have also affected health care systems outside the U.S., particularly in
+Europe, where the health care systems are generally government-run. The level of government budget deficits can have an adverse effect on the amount of government health care spend. 
+Sales, Marketing and Distribution 
+Our Diagnostics
+segment’s sales and distribution network consists of the following for each of the broad geographic regions we serve: 
+North
+America 
+In North America, our sales and distribution network consists of a direct sales force (U.S. only) complemented by independent
+distributors. The use of independent distributors in the U.S. allows our products to reach any size health care facility and also provides our customers the option to purchase our products directly from Meridian or through an authorized
+distributor. Two independent distributors in the U.S. accounted for 10% or more of consolidated net revenues in fiscal 2016, 2015 and 2014: Cardinal Healthcare Corporation and Thermo Fisher Scientific. Our revenues from Cardinal were
+approximately $20,000, $29,000 and $28,000 during fiscal 2016, 2015 and 2014, respectively. Our revenues from Thermo Fisher were approximately $20,000, $25,000 and $23,000 during fiscal 2016, 2015 and 2014, respectively. 
+EMEA 
+In EMEA, our sales
+and distribution network consists of direct sales forces in Belgium, France, Holland and Italy, and independent distributors in other European countries, Africa and the Middle East. We have implemented a direct sales presence in Germany and the
+U.K. for our illumi gene products, and utilize independent distributors for our immunoassay products. We maintain a distribution center near Milan, Italy. 
+ROW 
+With the exception
+of Australia, where we utilize a direct sales force, we utilize independent distributors throughout the ROW. 
+- 9 - 
+Table of Contents 
+Competition 
+Our major competitors in molecular diagnostics are Cepheid and Becton Dickinson, who have systems with multiple-assay menus. We also face competition in
+molecular diagnostics, but to a lesser degree, from companies such as Alere, Great Basin, Nanosphere and Quidel. These latter companies have a limited commercial menu and tend to compete strictly on price. We believe that our molecular
+platform offers a number of competitive features: 
+• 
+Molecular assay sensitivity that is comparable to higher costing PCR; 
+• 
+Low capital investment with no instrument service cost; 
+• 
+Small footprint that is portable and does not consume much laboratory space; and 
+• 
+Product menu that fits with initiatives to improve clinical and economic outcomes. 
+Our major competitors in
+rapid immunoassay diagnostics are primarily Alere and Quidel. These companies tend to compete strictly on price. For blood lead testing, we believe we have the only FDA-cleared, CLIA-waived point-of-care test available
+commercially. Other blood lead testing systems in use include Graphite Furnace Atomic Absorption Spectroscopy, which requires a highly-skilled technician and larger laboratory space to operate, in addition to not being portable or suitable for
+point-of-care use. We believe that with the breadth and depth of our product portfolio, we are well positioned for the clinical laboratory. 
+Research and Development 
+Our Diagnostics
+segment’s research and development organization for infectious disease products is located at our corporate headquarters in Newtown, Ohio, a suburb of Cincinnati, and has expertise in biochemistry, immunology, mycology, bacteriology, virology,
+parasitology, and molecular biology. Our Magellan business has a dedicated research and development team in Billerica, Massachusetts. Research and development expenses for the Diagnostics segment for fiscal 2016, 2015 and 2014 were
+approximately $11,000, $10,000 and $10,000, respectively. Our research and development activities are focused on new product and new technology development, new applications for our existing technologies, and improvements to existing
+products. Research and development efforts may occur in-house or with collaborative partners. We believe that new product development is a key source for sustaining revenue growth. The products within our
+illumi gene molecular platform, H. pylori product family and blood lead testing family were developed solely in-house, or substantially so. 
+Manufacturing 
+Our immunoassay and molecular
+products require the production of highly specific and sensitive antigens, antibodies, primers and enzymes. While we produce substantially all of our own requirements including monoclonal and polyclonal antibodies, and a variety of fungal,
+bacterial and viral antigens, currently a number of the raw materials used in our products, including our illumi gene molecular products, are purchased from outside vendors. With the expansion of our molecular diagnostic
+manufacturing capacity at our Cincinnati, Ohio location in recent years, we brought in-house certain molecular component manufacturing that was previously outsourced. Our blood lead testing products require the production of electrical chemical
+sensors, for which we produce all of our own requirements. We believe that we have sufficient manufacturing and sourcing capacity for anticipated growth over the next several years. 
+- 10 - 
+Table of Contents 
+Intellectual Property, Patents and Licenses 
+We own or license U.S. and foreign patents, most of which are for selected products manufactured by our Diagnostics segment. These patents are used in our
+manufacturing processes for selected products (method patents) or may relate to the design of the test device technology format (design patents). In the absence of patent protection, we may be vulnerable to competitors who successfully
+replicate our production and manufacturing technologies and processes. Our employees are required to sign confidentiality and non-disclosure agreements designed to protect our proprietary products. 
+The patents for our illumi gene products, which represented 20% and 21% of consolidated revenues for fiscal 2016 and fiscal 2015,
+respectively, are licensed from a third party, Eiken Chemical Co., Ltd., under a non-exclusive license agreement and expire between 2020 and 2022. These patents were issued in the U.S., European Community and other countries. The term
+of our license agreement runs until the last patent expires in 2022, at which point we will be free to practice the patents without any restriction or royalty obligation. 
+The patents for our H. pylori products, which represented 15% and 14% of consolidated revenues for fiscal 2016 and fiscal 2015, respectively, are
+owned by us and expired in May 2016 in the U.S., and will expire in fiscal 2017 in countries outside the U.S. We expect competition with respect to our H. pylori products to increase in fiscal 2017 as we currently market the only
+FDA-cleared tests to detect H. pylori antigen in stool samples. Such competition may have an adverse impact on our selling prices for these products or our ability to retain business at prices acceptable to us, and consequently,
+adversely affect our future results of operations and liquidity, including revenues and gross profit. In order to mitigate competition, our product development pipeline includes multiple new product initiatives for the detection of H.
+pylori . We are unable to provide assurances that we will be successful with any mitigation strategy or that any mitigation strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and
+gross profit. 
+Government Regulation 
+Our
+diagnostic products are regulated by the Food & Drug Administration (FDA) as “devices” pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of three classes (i.e.,
+Class I, II or III). Class I and II devices are not expressly approved by the FDA, but, instead, are “cleared” for marketing. Class III devices generally must receive “pre-market approval” from the FDA as to safety and
+effectiveness. 
+- 11 - 
+Table of Contents 
+Each of the diagnostic products currently marketed by us in the United States has been cleared by the FDA
+pursuant to the 510(k) clearance process or is exempt from such requirements. We believe that most, but not all, products under development will be classified as Class I or II medical devices and, in the case of most of our Class I and all
+Class II devices, will be eligible for 510(k) clearance; however, we can make no assurances in this regard. Meridian’s TRU FLU rapid influenza assay was cleared in 2006 as a Class I device. In May 2014, the FDA proposed reclassifying
+rapid influenza assays as a Class II device, requiring the submission of a new 510(k) application and subjecting TRU FLU and similar competitive devices to increased requirements for sensitivity. If the proposed rule becomes effective, Meridian
+will have one year to bring its assay up to the new requirements or remove it from the market. Sales of the TRU FLU product totaled approximately $1,000 in fiscal 2016. 
+Sales of our diagnostic products in foreign countries are subject to foreign government regulation, largely similar to that of the FDA. 
+Meridian’s Cincinnati manufacturing facility is certified to ISO 13485:2012, and the Magellan facility in Billerica, Massachusetts is certified to ISO
+9001:2008 and ISO 13485:2003. 
+Medical Device Tax 
+On January 1, 2013, the medical device tax established as part of the U.S. health care reform legislation became effective and as a result, the Company made
+its first required tax deposit near the end of January 2013. During fiscal 2016, 2015 and 2014, the Company recorded to cost of sales approximately $500, $1,900 and $1,750, respectively, of medical device tax expense related to this
+legislation. During December 2015, the Consolidations Appropriations Act of 2016 imposed a two-year moratorium on this excise tax effective January 1, 2016. During calendar years 2016 and 2017, this moratorium would result in approximately
+$2,000 of savings each year. We are unable to predict any future legislative changes or developments related to this moratorium or excise tax. 
+Seasonal Factors and Sporadic Outbreaks 
+Our
+principal business is the sale of a broad range of diagnostic test kits for common gastrointestinal, viral, upper respiratory, and parasitic infectious diseases, and elevated blood lead levels. Certain infectious diseases may be seasonal in
+nature, while others may be associated with sporadic outbreaks, such as foodborne illnesses or pandemics such as the H1N1 influenza outbreak during fiscal 2009. While we believe that the breadth of our diagnostic product lines reduces the risk
+that infections subject to seasonality and sporadic outbreaks will cause significant variability in diagnostic revenues, we can make no assurance that revenues will not be impacted period over period by such factors. 
+- 12 - 
+Table of Contents 
+Life Science Segment 
+Overview of Products and Markets 
+Our Life Science
+segment’s business focuses on the development, manufacture, sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers, agri-bio companies and other
+diagnostic manufacturing companies. Third-party revenues for this segment were approximately $51,000, $49,000 and $47,000 for fiscal 2016, 2015 and 2014, respectively. As of September 30, 2016, our Life Science segment had approximately
+210 employees in seven countries. 
+Most of the revenues for our Life Science segment currently come from the manufacture, sale and distribution of bulk
+antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturing companies focused on the development of immunoassay and molecular tests. Approximately 65% of
+Life Science revenues are generated from the industrial market, defined as diagnostic manufacturers and the agriculture industry. This continues to be an increasing focus of our Bioline molecular component business, which historically focused
+on the academic/research market that comprises the remaining 35% of Life Science revenues. We utilize direct sales teams in key countries such as the U.S., the U.K., Germany, France, Australia and Singapore. Opened in 2013, the Singapore
+sales and business development office is designed to increase our presence and our revenue opportunities in Asia for both molecular and immunoassay components. Additionally, in order to further pursue revenue opportunities in Asia, and China in
+particular, during fiscal 2015 we opened a representative office in Beijing, China. We utilize a network of distributors in other major countries. During fiscal 2016, 18% of third-party revenues for this segment were from two diagnostic
+manufacturing customers. 
+Products such as antibodies, antigens and reagents are marketed primarily to diagnostic manufacturing customers as a source of
+raw materials for their immunoassay products, or as an outsourced step in their manufacturing processes. For example, we supply a number of major diagnostic manufacturers with proteins used to detect hepatitis A and rubella. These products
+are typically sold in bulk quantities, and may also be custom-designed for a particular manufacturer’s requirements. Sales efforts are focused on multi-year supply arrangements in order to provide stability in volumes and pricing. We
+believe this benefits both us and our customers. 
+Molecular biology products such as PCR/qPCR reagents, nucleotides and competent cells are marketed to
+academic/research and industrial customers. These products are used in measuring DNA and RNA in clinical and agricultural applications. These reagents improve the purity, yield and speed of PCR reactions. Products such as MyTaq and SensiFAST are examples of this type of PCR/qPCR reagent. 
+- 13 - 
+Table of Contents 
+Market Trends 
+As certain global markets become increasingly accessible to us, most notably China, geographic expansion continues to be a significant strategy for our Life
+Science segment, along with further penetration into industrial markets with our molecular products. 
+Competition 
+The market for bulk biomedical reagents is highly competitive. Important competitive factors include product quality, price, customer service and
+reputation. We face competitors, many of which have greater financial, research and development, sales and marketing, and manufacturing resources, and where sole-source supply arrangements do not exist. Customers also may choose to
+manufacture their biomedical reagents in-house rather than purchase from outside vendors such as Meridian. 
+The academic/research market is highly
+fragmented. Individual purchases are typically of small quantities. The breadth of product offerings, quality, price and service, including on-line capabilities and technical resources, are important factors to building customer loyalty
+and repeat purchases. 
+Research and Development 
+Research and development expenses for our Life Science segment for each of fiscal 2016, 2015 and 2014 were approximately $3,000. The primary focus of this
+research and development organization is development of new molecular reagent products. 
+Manufacturing and Government Regulation 
+Our Life Science U.S. facilities are ISO 9001:2008 certified and our Bioline facilities in the U.K. and Germany are ISO 13485:2012
+certified. Additionally, where appropriate, our Life Science facilities comply with Regulation EC 1069:2009. 
+Acquisitions 
+Acquisitions have played an important role in the growth of our businesses. Our acquisition objectives include, among other things: (i) enhancing product
+offerings; (ii) improving product distribution capabilities; (iii) providing access to new markets; and/or (iv) providing access to key biologicals or new technologies that lead to new products. Although we cannot provide assurance that we will
+consummate additional acquisitions in the future, nor can we provide assurance that any acquisitions will accomplish these objectives, we expect that the potential for acquisitions will continue to provide opportunities for revenue and earnings
+growth in the future. 
+As previously noted in the Overview section, during March 2016, we acquired all of the outstanding common stock of
+Magellan. Headquartered near Boston, Massachusetts, Magellan is a leading manufacturer of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults. Magellan is the leading provider of point-of-care
+lead testing systems in the U.S. 
+- 14 - 
+Table of Contents 
+International Markets 
+International markets are an important source of revenues and future growth opportunities for both of our segments. For both segments combined, revenues
+from customers located outside of the Americas approximated $52,000 or 26% of consolidated fiscal 2016 revenues, $49,000 or 25% of consolidated fiscal 2015 revenues, and $55,000 or 29% of consolidated fiscal 2014 revenues. We expect to continue
+to look to international markets as a source of revenue growth in the future. 
+During fiscal 2016, currency exchange had an approximate $1,700 unfavorable
+impact on revenues; $700 within the Diagnostics segment and $1,000 within the Life Science segment. This compares to currency exchange rates having an approximate $4,700 unfavorable impact on revenues in fiscal 2015; $3,200 within the
+Diagnostics segment and $1,500 within the Life Science segment. Due to natural hedge relationships with expenses, both cost of sales and operating expenses, the overall impact of exchange rate fluctuations on net earnings was not significant
+during fiscal 2016, 2015 or 2014. 
+Environmental 
+We
+are in compliance with applicable portions of the federal and state hazardous waste regulations and have never been a party to any environmental proceeding.

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+Item 13 
+Certain Relationships and Related Transactions, and Director Independence 
+78

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+ITEM 9A. 
+CONTROLS AND PROCEDURES 
+As of September 30, 2016, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive
+Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended. Based on
+that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of September 30, 2016. Noting that the Company’s assessment of and conclusion on the effectiveness of its
+internal control over financial reporting did not include the internal controls of Magellan Biosciences, Inc., which was acquired during fiscal 2016 and the results of which since the date of acquisition were included in the 2016 consolidated
+financial statements, there have been no changes in our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the fourth fiscal quarter that has materially affected, or is
+reasonably likely to affect, our internal control over financial reporting, or in other factors that could significantly affect internal control subsequent to September 30, 2016. 
+Our internal control report is included in this Annual Report on Form 10-K after Item 8, under the caption “Management’s Report on Internal Control
+over Financial Reporting.”

raw/filings/0000794172/2016/0001193125-16-779250/rpt_disclosure.txt

@@ -0,0 +1,15 @@
+TRANSACTIONS WITH RELATED PERSONS 
+During fiscal 2017, the Company leased certain office space from an entity controlled by Marco G. Calzavara, President and Managing Director, Meridian
+Bioscience Europe. Payments made under such arrangements during fiscal 2017 totaled approximately $150,000. 
+Nasdaq rules require the
+Company to conduct an appropriate review of related party transactions required to be disclosed by the Company pursuant to SEC Regulation S-K Item 404 for potential conflict of interest situations on an
+ongoing basis and that all such transactions must be approved by the Audit Committee or another Committee comprised of independent Directors. As a result, the Audit Committee annually reviews all such related party transactions and approves each
+related party transaction if it determines that it is in the best interests of the Company. Additionally, the Audit Committee’s Charter provides it the authority to review, approve and monitor transactions involving the Company and
+“related persons” (Directors and Executive Officers or their immediate family members, or shareholders owning five percent or greater of the Company’s outstanding stock). This also covers any related person transaction that meets the
+minimum threshold for disclosure in the proxy statement under the relevant SEC rules (generally, transactions involving amounts exceeding $120,000 in which a related person has a direct or indirect material interest). In
+considering the transaction, the Audit Committee may consider all relevant factors, including, as applicable: (i) the Company’s business rationale for entering into the transaction; (ii) the alternatives to entering into a related
+person transaction; (iii) whether the transaction is on terms comparable to those available to third parties, or in the case of employment relationships, to employees generally; (iv) the potential for
+15 
+Table of Contents 
+the transaction to lead to an actual or apparent conflict of interest and any safeguards imposed to prevent such actual or apparent conflicts; and (v) the overall fairness of the transaction
+to the Company. This policy is included in the Company’s Employee Handbook. The approval of such related person transactions are evidenced by internal Company resolutions or memoranda.

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raw/filings/0000794172/2017/0001193125-17-354808/item1.txt

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+ITEM 1. 
+BUSINESS 
+Overview
+Meridian is a fully-integrated life science company with principal businesses in (i) the development, manufacture, sale and distribution of
+diagnostic test kits, primarily for certain gastrointestinal, viral, respiratory, and parasitic infectious diseases, and elevated blood lead levels; and (ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents,
+nucleotides, competent cells, and bioresearch reagents used by researchers and other diagnostic manufacturers. The Company was incorporated in Ohio in 1976. Our principal corporate offices are located near Cincinnati, Ohio, USA. 
+During March 2016, we acquired all of the outstanding common stock of Magellan Biosciences, Inc., and its wholly-owned subsidiary Magellan Diagnostics, Inc.
+(collectively, “Magellan”), which is now reported as part of our Diagnostics operating segment. Headquartered near Boston, Massachusetts, Magellan is a leading manufacturer of products cleared by the Food & Drug Administration
+(“FDA”) for the point-of-care testing of capillary blood to diagnose lead poisoning in children and adults. Further details of the Magellan acquisition are set
+forth in Note 2 of the accompanying Consolidated Financial Statements. 
+- 5 - 
+Table of Contents 
+Our website is www.meridianbioscience.com . We make available our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments thereto, free of charge through this website, as
+soon as reasonably practicable after such material has been electronically filed with or furnished to the Securities and Exchange Commission (“SEC”). These reports may also be read and copied at the SEC’s public reference room at 100
+F Street, N.E., Washington, DC 20549, phone number 1-800-732-0330. The SEC maintains an internet site containing these filings
+and other information regarding Meridian at www.sec.gov . The information on our website is not and should not be considered part of this Annual Report on Form 10-K. 
+Reportable Segments 
+Our reportable segments are
+Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio. Detailed information related to the reportable segments can be found in the following locations within this Annual Report on Form
+10-K: 
+Type of Segment Information 
+Location within Annual Report on Form 10-K 
+Physical locations and activities

raw/filings/0000794172/2017/0001193125-17-354808/item13.txt

@@ -0,0 +1,3 @@
+Item 13 
+Certain Relationships and Related Transactions, and Director Independence
+84

raw/filings/0000794172/2017/0001193125-17-354808/item9a.txt

@@ -0,0 +1,3 @@
+Item 9A 
+Controls and Procedures 
+82

raw/filings/0000794172/2017/0001193125-17-354808/rpt_disclosure.txt

@@ -0,0 +1,16 @@
+TRANSACTIONS WITH RELATED PERSONS 
+During fiscal 2018, the Company leased certain office space from an entity controlled by Marco G. Calzavara, who served as President and Managing Director, Meridian Bioscience Europe through July
+2018. Payments made under such arrangements during fiscal 2018 totaled approximately $160,000. 
+Nasdaq rules require the Company to
+conduct an appropriate review of related party transactions required to be disclosed by the Company pursuant to SEC Regulation S-K Item 404 for potential conflict of interest situations on an ongoing basis and
+that all such transactions must be approved by the Audit Committee or another Committee comprised of independent Directors. As a result, the Audit Committee annually reviews all such related party transactions and approves each related party
+transaction if it determines that it is in the best interests of the Company. Additionally, the Audit Committee’s Charter provides it the authority to review, approve and monitor transactions involving the Company and “related
+persons” (Directors and Executive Officers or their immediate family members, or shareholders owning five percent or greater of the Company’s outstanding stock). This also covers any related person transaction that meets the minimum
+threshold for disclosure in the proxy statement under 
+14 
+Table of Contents 
+the relevant SEC rules (generally, transactions involving amounts exceeding $120,000 in which a related person has a direct or indirect material interest). In considering
+the transaction, the Audit Committee may consider all relevant factors, including, as applicable: (i) the Company’s business rationale for entering into the transaction; (ii) the alternatives to entering into a related person
+transaction; (iii) whether the transaction is on terms comparable to those available to third parties, or in the case of employment relationships, to employees generally; (iv) the potential for the transaction to lead to an actual or
+apparent conflict of interest and any safeguards imposed to prevent such actual or apparent conflicts; and (v) the overall fairness of the transaction to the Company. This policy is included in the Company’s Employee Handbook. The
+approvals of such related person transactions are evidenced by internal Company resolutions, minutes or memoranda.

raw/filings/0000794172/2021/0001193125-21-337663/filing_metadata.csv

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+cik,ticker,company_name,form,filing_date,report_date,acceptance_datetime,accession_number,primary_document,primary_doc_description,size,is_xbrl,is_inline_xbrl,document_url,filing_index_url,year,fiscal_year,is_primary_filing
+0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2021-11-23,2021-09-30,2021-11-23T13:46:09.000Z,0001193125-21-337663,d228317d10k.htm,10-K,11880738,1,1,https://www.sec.gov/Archives/edgar/data/794172/000119312521337663/d228317d10k.htm,https://www.sec.gov/Archives/edgar/data/794172/000119312521337663/,2021,2021,1

raw/filings/0000794172/2021/0001193125-21-337663/item1.txt

@@ -0,0 +1,22 @@
+ITEM 1. 
+BUSINESS 
+Overview 
+Meridian is a fully-integrated life science company with principal businesses in: (i) the development, manufacture, sale and distribution of diagnostic testing systems and kits, primarily for certain gastrointestinal and respiratory infectious diseases, and elevated blood lead levels; and (ii) the manufacture and distribution of bulk antigens, antibodies, immunoassay blocking reagents, specialized Polymerase Chain Reaction (“PCR”) master mixes, and bioresearch reagents used by other diagnostic test manufacturers and researchers in immunological and molecular tests for human, animal, plant and environmental applications. 
+Our website is 
+www.meridianbioscience.com 
+. We make available our Annual Reports on Form 
+10-K, 
+Quarterly Reports on Form 
+10-Q, 
+Current Reports on Form 
+8-K, 
+Proxy Statements and any amendments thereto, free of charge through this website, as soon as reasonably practicable after such material has been electronically filed with or furnished to the SEC. The SEC maintains an internet site containing these filings and other information regarding Meridian at 
+www.sec.gov 
+. The information on our website is not and should not be considered part of this Form 
+10-K. 
+Reportable Segments 
+Our reportable segments are Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio. We describe these reportable segments in this “Business” section and in other locations in this report: 
+Type of Segment Information 
+Location within Form 
+10-K 
+Physical locations and activities

raw/filings/0000794172/2021/0001193125-21-337663/item13.txt

@@ -0,0 +1,3 @@
+ITEM 13. 
+CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 
+The information set forth in the Proxy Statement under the captions “Corporate Governance” and “Transactions with Related Persons” is incorporated herein by reference.

raw/filings/0000794172/2021/0001193125-21-337663/item9a.txt

@@ -0,0 +1,6 @@
+ITEM 9A. 
+CONTROLS AND PROCEDURES 
+As of September 30, 2021, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of September 30, 2021. There have been no changes in our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the fourth fiscal quarter that has materially affected, or is reasonably likely to affect, our internal control over financial reporting, or in other factors that could significantly affect internal control subsequent to September 30, 2021. 
+Our internal control report is included in this Form 10-K after Item 8, under the caption “Management’s Report on Internal Control over Financial Reporting.” 
+- 74 - 
+Table of Contents

raw/filings/0000794172/2021/0001193125-21-337663/rpt_disclosure.txt

@@ -0,0 +1,9 @@
+TRANSACTIONS WITH RELATED PERSONS 
+Nasdaq rules require the Company to conduct an appropriate review of related party transactions required to be disclosed by the Company pursuant to SEC Regulation S-K Item 404 for potential conflict of interest situations on an ongoing basis and that all such transactions must be approved by the Audit Committee or another Committee comprised of independent directors. As a
+result, the Audit Committee annually reviews all such related party transactions and approves each related party transaction if it determines that it is in the best interests of the Company. Additionally, the Audit Committee’s Charter provides
+it the authority to review, approve and monitor transactions involving the Company and “related persons” (directors and executive officers or their immediate family members, or shareholders owning five percent or greater of the
+Company’s outstanding stock). This also covers any related person transaction that meets the minimum threshold for disclosure in the proxy statement under the relevant SEC rules (generally, transactions involving amounts exceeding $120,000 in
+which a related person has a direct or indirect material interest). In considering the transaction, the Audit Committee may consider all relevant factors, including, as applicable: (i) the Company’s business rationale for entering into the
+transaction; (ii) the alternatives to entering into a related person transaction; (iii) whether the transaction is on terms comparable to those available to third parties, or in the case of employment relationships, to employees generally;
+(iv) the potential for the transaction to lead to an actual or apparent conflict of interest and any safeguards imposed to prevent such actual or apparent conflicts; and (v) the overall fairness of the transaction to the Company. This
+policy is included in the Company’s Employee Handbook. The approvals of such related person transactions are evidenced by internal Company resolutions, minutes or memoranda.

raw/filings/0000794172/2022/0001193125-22-290521/filing_metadata.csv

@@ -0,0 +1,2 @@
+cik,ticker,company_name,form,filing_date,report_date,acceptance_datetime,accession_number,primary_document,primary_doc_description,size,is_xbrl,is_inline_xbrl,document_url,filing_index_url,year,fiscal_year,is_primary_filing
+0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2022-11-22,2022-09-30,2022-11-22T13:27:38.000Z,0001193125-22-290521,d384542d10k.htm,10-K,10762042,1,1,https://www.sec.gov/Archives/edgar/data/794172/000119312522290521/d384542d10k.htm,https://www.sec.gov/Archives/edgar/data/794172/000119312522290521/,2022,2022,1

raw/filings/0000794172/2022/0001193125-22-290521/item1.txt

@@ -0,0 +1,14 @@
+ITEM 1. 
+BUSINESS 
+Overview 
+Meridian is a fully-integrated life science company with principal businesses in: (i) the development, manufacture, sale and distribution of diagnostic testing systems and kits, primarily for certain gastrointestinal and respiratory infectious diseases, and elevated blood lead levels; and (ii) the manufacture and distribution of bulk antigens, antibodies, immunoassay blocking reagents, specialized Polymerase Chain Reaction (“PCR”) master mixes, and bioresearch reagents used by other diagnostic test manufacturers and researchers in immunological and molecular tests for human, animal, plant and environmental applications. 
+Our website is www.meridianbioscience.com . We make available our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Proxy Statements and any amendments thereto, free of charge through this website, as soon as reasonably practicable after such material has been electronically filed with or furnished to the SEC. The SEC maintains an internet site containing these filings and other information regarding Meridian at www.sec.gov . The information on our website is not and should not be considered part of this Form 10-K. 
+Pending Merger 
+On July 7, 2022, the Company entered into an Agreement and Plan of Merger (as it may be amended, supplemented or otherwise modified from time to time, the “Merger Agreement”) with SD Biosensor, Inc., a corporation with limited liability organized under the laws of the Republic of Korea (“SDB”), Columbus Holding Company, a Delaware corporation (“Parent”), and Madeira Acquisition Corp., an Ohio corporation and a direct wholly owned subsidiary of Parent (“Merger Sub”). Meridian is informed that SJL Partners, LLC (“SJL”) is currently the sole shareholder of Parent, and SDB together with SJL will be the sole shareholders of Parent as of the closing of the Merger. Pursuant to the Merger Agreement, Merger Sub will merge with and into Meridian (the “Merger”), with Meridian surviving the Merger as a direct wholly owned subsidiary of Parent. Consummation of the Merger is subject to customary closing conditions, including, without limitation: (i) the absence of certain legal impediments; and (ii) the condition that no Specified Outcome, as such term is defined in the Merger Agreement, related to the DOJ LeadCare legal matter (which is described in the section entitled “Legal Matter Relating to LeadCare Product Line” of Item 3. “Legal Proceedings”) has occurred or is reasonably likely to occur. 
+On November 21, 2022, the parties received clearance from the Committee on Foreign Investment in the United States with respect to the Merger and the transactions contemplated by the Merger Agreement. 
+The foregoing description of the Merger Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Merger Agreement, which is attached as an exhibit to our Current Report on Form 8-K filed with the SEC on July 7, 2022. 
+Reportable Segments 
+Our reportable segments are Diagnostics and Life Science, both of which are headquartered in Cincinnati, Ohio. We describe these reportable segments in this “Business” section and in other locations in this report: 
+Type of Segment Information 
+Location within Form 10-K 
+Physical locations and activities

raw/filings/0000794172/2022/0001193125-22-290521/item13.txt

@@ -0,0 +1,3 @@
+Item 13 
+Certain Relationships and Related Transactions, and Director Independence 
+75

raw/filings/0000794172/2022/0001193125-22-290521/item9a.txt

@@ -0,0 +1,6 @@
+ITEM 9A. 
+CONTROLS AND PROCEDURES 
+As of September 30, 2022, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of September 30, 2022. There have been no changes in our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the fourth fiscal quarter that has materially affected, or is reasonably likely to affect, our internal control over financial reporting, or in other factors that could significantly affect internal control subsequent to September 30, 2022. 
+Our internal control report is included in this Form 10-K after Item 8, under the caption “Management’s Report on Internal Control over Financial Reporting.” 
+- 74 - 
+Table of Contents

raw/filings/0001116463/2019/0001564590-20-008195/filing_metadata.csv

@@ -0,0 +1,2 @@
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+0001116463,OSUR,ORASURE TECHNOLOGIES INC,10-K,2020-03-02,2019-12-31,2020-03-02T22:02:27.000Z,0001564590-20-008195,osur-10k_20191231.htm,10-K,18171245,1,1,https://www.sec.gov/Archives/edgar/data/1116463/000156459020008195/osur-10k_20191231.htm,https://www.sec.gov/Archives/edgar/data/1116463/000156459020008195/,2019,2019,1

raw/filings/0001116463/2019/0001564590-20-008195/item1.txt

@@ -0,0 +1,270 @@
+ITEM 1. 
+Business. 
+The overall goal of our Company is to empower the global community to improve health and wellness by providing access to accurate essential information. Our business is made up of two principal segments. The first is our “OSUR” business, which consists of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using our proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Our diagnostic products include tests for diseases including HIV and Hepatitis C that are performed on a rapid basis at the point of care and tests that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. Our HIV product is also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and as a self-test to individuals in a number of other countries. 
+The second segment is our “DNAG” or molecular products and services business and is operated primarily through our subsidiaries, DNA Genotek Inc. (“DNAG”), a company based in Ottawa, Canada, CoreBiome, Inc. (“CoreBiome”), Diversigen, Inc. (“Diversigen”) and Novosanis NV (“Novosanis”). In the DNAG business, we manufacture and sell kits that are used to collect, stabilize, transport and store biological samples of genetic material for molecular testing. Our products are used for academic research and commercial applications, including ancestry, disease risk management, lifestyle and animal testing. Included in the disease risk management area are pharmacogenomics testing, hereditary disease screening, prenatal or cancer screening, population health initiatives and other molecular testing using DNA or RNA for diagnosis of acute disease. Our Oragene ® DNA sample collection kit provides an all-in-one system for the collection, stabilization, transportation and storage of DNA from human saliva. We also sell research use only collection products into the microbiome market. We offer our customers a suite of genomics and microbiome services that range from package customization and study design optimization to extraction, analysis and reporting services. The microbiome laboratory and bioinformatics services are provided by CoreBiome and Diversigen. Novosanis manufactures and sells the Colli-Pee ® collection device for the volumetric collection of first-void urine for use in research, screening and diagnostics in the liquid biopsy and sexually transmitted infection markets. Our DNAG business serves customers in many countries worldwide, including many leading research universities and hospitals. 
+OraSure was formed in May 2000 under Delaware law solely for the purposes of combining two companies, STC Technologies, Inc. (“STC Technologies”) and Epitope, Inc. (“Epitope”), and changing the state of incorporation of Epitope from Oregon to Delaware. STC Technologies and Epitope were merged into OraSure on September 29, 2000. Our principal offices are located at 220 East First Street, Bethlehem, Pennsylvania 18015, and our telephone number is (610) 882-1820. 
+Additional information about us can be found on our website, www.orasure.com . We make available free of charge through a link provided at such website our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and our other filings with the Securities and Exchange Commission (“SEC”), as well as any amendments to those Reports and filings. These Reports and filings are made available as soon as reasonably practicable after they are filed with or furnished to the SEC. Our website and the information contained in or connected to that website are not intended to be incorporated by reference into this Annual Report. 
+2019 Developments 
+In early January 2019, we acquired two privately-held, early-stage companies, CoreBiome and Novosanis, in order to add differentiated products and services to the molecular collection systems segment of our business. 
+CoreBiome, a spin-off from the University of Minnesota, is based in St. Paul, Minnesota and provides microbiome laboratory and analytical services that can accelerate research and discovery for customers in the pharmaceutical, agricultural and academic research communities. CoreBiome was co-founded in 2016 by Dr. Dan Knights, a globally-recognized expert in microbiome informatics who has developed leading methods for analyzing microbiome data, along with Dr. Daryl Gohl and Dr. Kenny Beckman, domain experts in microbiome sample processing and analysis. 
+Novosanis is a Belgian company that was founded in 2013 as a spin-off from the University of Antwerp, Belgium. Novosanis is an early commercial stage producer and distributor of urine sample collection devices targeting the liquid biopsy and sexually transmitted infection screening markets. Novosanis’ primary product is Colli-Pee, an easy to use device designed for the standardized collection of first-void urine which can be used in the privacy of the user’s home or in a clinic. Product validation and clinical trials are also under way with various sexually transmitted infection test manufacturers. 
+2 
+I n August 2019, we sold our cryosurgical systems line of business to a third party . This line of business consisted of medical devices used for the removal of benign skin lesions by cryosurgery or freezing. 
+In November 2019, we acquired another microbiome laboratory services provider, Diversigen. Based in Houston, Texas, Diversigen provides science-driven, customized solutions for metagenomics sequencing, bioinformatics, and statistical analysis for the study of the microbiome. The company was founded in 2013 by Dr. Joseph Petrosino, director of the Alkek Center for Metagenomics and Microbiome Research at the Baylor College of Medicine (“BCM”), where Diversigen was a BCM portfolio company. Diversigen was the first company to establish microbiome protocols in accordance with College of American Pathologists (“CAP”) accreditation and Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) guidelines. 
+OSUR Segment Products 
+The following is a summary of our principal products for the infectious disease and risk management markets, which comprise the OSUR segment of our business: 
+OraQuick ® Rapid HIV Test 
+OraQuick ® is our rapid point-of-care test platform designed to test oral fluid, whole blood (i.e., both finger-stick and venous), plasma and serum samples for the presence of various antibodies or analytes. The device uses a porous flat pad to collect an oral fluid specimen. After collection, the pad is inserted into a vial containing a pre-measured amount of developer solution and allowed to develop. When blood, plasma or serum is to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer solution, after which the collection pad is inserted into the solution and allowed to develop. In all cases, the specimen and developer solution then flow through the testing device where test results are observable in approximately 20 minutes. The OraQuick ® device is a screening test and generally requires a confirmation test where an initial positive result is obtained. 
+This product is sold under the OraQuick ADVANCE ® name in North America, Europe and certain other countries and under the OraQuick ® name in other developing countries. The test has received pre-market approval (“PMA”) from the FDA for the detection of antibodies to both HIV-1 and HIV-2 in oral fluid, finger-stick whole blood, venous whole blood and plasma. This test is available for use by laboratories located in the United States certified under the Clinical Laboratory Improvements Amendment of 1988 (“CLIA”), to perform moderately complex tests. We have also received a CLIA waiver for use of the test with oral fluid and finger-stick and venous whole blood. As a result, the test can be used by numerous additional sites in the United States not certified under CLIA to perform moderately complex tests, such as outreach clinics, community-based organizations and physicians’ offices. 
+On the international front, we have obtained a CE mark for our OraQuick ADVANCE ® test so that we can sell this product in Europe and other countries accepting the CE mark for commercialization and this product is registered for sale in other countries. We have distributors in place for several countries and are seeking to increase awareness and expand our distribution network for this product throughout the world. We have also received World Health Organization (“WHO”) pre-qualification for our export-only version of this product. 
+OraQuick ® In-Home HIV Test 
+The OraQuick ® In-Home HIV test is an OTC oral-fluid only version of our OraQuick ADVANCE ® HIV 1/2 Antibody Test. We received PMA approval to sell this test in the U.S. OTC market. We have also received a CE mark for the OraQuick ® In-Home HIV test, although this product is not currently sold in the European Union. The In-Home test is performed in the same manner as the OraQuick ADVANCE ® test, except that it has product labeling and instructions designed for consumers. In addition, we have established toll-free, 24/7, 365-day per year customer telephone support to provide additional information and referral services for consumers that use this product. 
+OraQuick ® HIV Self-Test 
+The OraQuick ® HIV Self-Test uses the same diagnostic technology as our U.S. approved OraQuick ADVANCE ® HIV test but is sold for use by individuals in certain foreign countries at a lower cost to meet the needs of those markets. For the past several years, we worked with Population Services International (“PSI”), a leading global health organization, along with UNITAID, the WHO and health officials from several African countries to deploy our Self-Test through the UNITAID-PSI HIV Self-Testing in Africa (“STAR”) project. The OraQuick ® Self-Test has labeling and instructions specifically tailored for each market in which it is sold. The purpose of the STAR project was to generate crucial information about how best to deliver HIV self-testing, how to generate demand for HIV testing in this manner and what the potential public health impact of self-testing will be. Our OraQuick ® Self-Test was chosen by PSI because of its quality, ease-of-use and oral fluid option. The STAR project has largely been completed. This product has received WHO pre-qualification and is eligible for procurement by purchasing entities entitled to access funding and other resources from the Global Fund, UNITAID and other agencies. During 2019, a majority of the sales of our OraQuick ® HIV Self-Test occurred in countries outside of the African countries covered by the STAR project. 
+3 
+OraQuick ® HCV Rapid Antibody Test 
+Another test available on the OraQuick ® platform is the OraQuick ® HCV rapid antibody test. This product is a qualitative test that can detect antibodies to the hepatitis C virus (“HCV”), in a variety of sample types. The OraQuick ® HCV test operates in substantially the same manner as the OraQuick ADVANCE ® HIV test. 
+We have received FDA approval and CLIA waiver for use of the test in detecting HCV antibodies in venous whole blood and finger-stick whole blood specimens, making it the first and only rapid HCV test approved by the FDA for use in the United States. The OraQuick ® HCV test has received a CE mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum and is sold in Europe. This CE-marked product is also registered and sold in other foreign countries and has received WHO pre-qualification. 
+OraQuick ® Ebola Rapid Antigen Test 
+In 2019, we received 510(k) clearance from the FDA for our new rapid Ebola test, making it the first and only rapid Ebola test cleared for sale in the U.S. This product utilizes the OraQuick ® technology platform for the detection of Ebola antigen. Under this 510(k) clearance, which came through the FDA’s Breakthrough Devices Program that allows for expedited clearance for treatment or diagnosis of life-threatening or increasingly debilitating diseases, our test can be used with finger-stick and whole blood samples from live patients and oral fluid samples from recently deceased individuals. The uses for this test are limited to individuals that meet certain criteria indicating they may be infected with the Ebola virus, so the test is not available for general screening of individuals that do not meet this criteria. This test had previously received emergency use authorization (“EUA”) from the FDA for emergency use by laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection (including treatment centers and public health clinics). The WHO also previously issued an Emergency Use Assessment and Listing for this product. 
+OraSure QuickFlu ® Rapid Flu A&B Test 
+The OraSure QuickFlu ® Rapid Flu A&B test is an FDA 510(k) cleared rapid qualitative test for the detection of influenza (flu) Types A and B, including H1N1 viral infections. The test utilizes specimen collected with a nasal swab, nasopharyngeal swab or nasal aspirate/wash. A reagent is first inserted into a test cartridge, the specimen is added and the test is allowed to flow. Results are available in as little as 10 minutes. This product is manufactured for us under an agreement with a third party and is currently sold in certain U.S. markets. The manufacturer of this product has also obtained a CLIA waiver for use of the test with nasal and nasopharyngeal swabs. 
+OraSure ® Collection Device 
+Our OraSure ® oral fluid collection device is used in conjunction with screening and confirmatory tests for HIV-1 antibodies. The generic version of this product can be used for other analytes. This device consists of a small, treated cotton-fiber pad on a handle that is placed in a person’s mouth for two to five minutes. The device collects oral mucosal transudate (“OMT”), a serum-derived fluid that contains higher concentrations of certain antibodies and analytes than saliva. As a result, OMT testing is a highly accurate method for detecting HIV-1 infection and other analytes. 
+The OraSure ® collection device is FDA approved for use in the detection of HIV-1 antibodies. The generic version is a Class I medical device for the detection of cocaine and cotinine in oral fluid specimens for risk assessment testing. HIV-1 antibody detection using the OraSure ® collection device involves three steps: 
+• 
+Collection of an oral fluid specimen using the OraSure ® device; 
+• 
+Screening of the specimen for HIV-1 antibodies at a laboratory with an enzyme immunoassay (“EIA”) screening test approved by the FDA for use with the OraSure ® device; and 
+• 
+Laboratory confirmation of any positive screening test results with either a western blot confirmatory test or a blood based nucleic acid test. 
+A trained health care professional then conveys test results and provides appropriate counseling to the individual who was tested. 
+Tuberculosis (“TB”) Products 
+OMNIgene ® • SPUTUM is a non-toxic and highly stable reagent that liquefies and decontaminates sputum samples at the point-of-collection or in the lab while preserving the viability of TB bacteria for at least eight (8) days at ambient temperatures. 
+Although the OMNIgene ® • SPUTUM product is CE marked and was being evaluated by a number of TB laboratories, demand for this product has not met expectations. Accordingly, we decided to stop selling this product in the second half of 2019. 
+4 
+Intercept ® Drug Testing System 
+A collection device that is substantially similar to the OraSure ® device is sold under the name Intercept ® , and is used to collect oral mucosal transudate or OMT for oral fluid drug testing. We have received FDA 510(k) clearance to use the Intercept ® collection device with laboratory-based EIAs to test for drugs-of-abuse commonly identified by the National Institute for Drug Abuse (“NIDA”) as the NIDA-5 (i.e., tetrahydrocannabinol (“THC” or marijuana), cocaine, opiates, amphetamines/methamphetamines and phencyclidine (“PCP”)), and for barbiturates, methadone and benzodiazepines. Each of these EIAs is also FDA 510(k) cleared for use with the Intercept ® device. Our Intercept ® device and oral fluid assays are sold in the U.S. primarily through laboratory distributors. 
+We believe that the Intercept ® device has several advantages over competing urine and other drugs-of-abuse testing products, including its lower total testing cost, its non-invasive nature, mobility and accuracy, the ease of maintaining a chain-of-custody, the treatment of test subjects with greater dignity, no requirement for specially-prepared collection facilities and difficulty of sample adulteration. The availability of an oral fluid test is intended to allow our customers to test for drug impairment and eliminate scheduling costs and inconvenience, thereby streamlining the testing process. 
+We have also developed a next-generation collection device, which we are marketing under the tradename “Intercept i2 ® he ”. This device offers several important advantages over our original Intercept ® device, including a sample adequacy indicator that provides a visual prompt when the appropriate volume of oral fluid has been collected, the ability to collect a larger sample required by current laboratory testing protocols and a more optimized chemistry that results in improved recovery of the targeted drug analytes. The Intercept i2 ® he device is currently being sold as a forensic use only device within the criminal justice and drug treatment markets along with a NIDA-5 panel of fully-automated high-throughput oral fluid drug assays that we distribute under an agreement with Thermo Fisher Scientific (“Thermo Fisher”). Under an amendment to the Thermo Fisher agreement, we have agreed to modify the configuration of our Intercept i2 ® he device and Thermo Fisher will further optimize its assays and related calibrators in order to meet recently issued oral fluid drug testing guidelines issued by the Substance Abuse and Mental Health Services Administration (“SAMHSA”). We also intend to obtain FDA 510(k) clearance of our device for use with a 12-assay panel of the Thermo Fisher assays. 
+Immunoassay Tests and Reagents 
+We develop and sell immunoassay tests in formats, known as MICRO-PLATE and AUTO-LYTE ® , to meet the specific needs of our customers. We also sell fully-automated high-throughput oral fluid drug assays developed under our agreement with Thermo Fisher. 
+In a MICRO-PLATE kit, the sample to be tested is placed into a small plastic receptacle, called a microwell, along with the reagents. The result of the test is determined by the color of the microwell upon completion of the reaction. Controlling the reaction involves the use of reagents by laboratory personnel. Test results are analyzed by any of a variety of commercially available laboratory instruments, which we may also provide to our laboratory customers. MICRO-PLATE tests can be performed on commonly used instruments and can detect drugs in urine, serum and sweat specimens. MICRO-PLATE tests are also used as part of the Intercept ® product line to detect drugs-of-abuse in oral fluid specimens. 
+AUTO-LYTE ® tests are sold in the form of bottles of liquid reagents. These reagents are run on commercially available laboratory-based automated analytical instruments, which are manufactured by a variety of third parties. AUTO-LYTE ® is typically used in high volume, automated, commercial reference insurance laboratories to detect certain drugs or chemicals in urine. Test results are produced quickly, allowing for high throughput. Our AUTO-LYTE ® tests continue to face strong competition from cheaper “home-brew” tests developed internally by our laboratory customers. As a result, we may eventually stop selling our AUTO-LYTE ® tests. 
+We previously entered into an agreement with Thermo Fisher under which Thermo Fisher would develop and supply up to 12 fully-automated high-throughput oral fluid drug assays for use with our Intercept i2 ® device. Under this agreement, we are currently selling a NIDA-5 panel of assays supplied by Thermo Fisher in the U.S. forensic market. As noted above, the parties amended this agreement and have agreed to modify our Intercept i2 ® collector and optimize the assays and related calibrators to meet recently issued SAMHSA drug testing guidelines and to pursue FDA 510(k) clearance of the Intercept i2 ® device for use with a 12-assay panel. We believe the offering of an Intercept i2 ® device with a full menu of fully-automated high-throughput oral fluid assays that meet the SAMHSA guidelines will better meet the needs of our laboratory drug testing customers and allow us to compete more effectively against fully automated urine drug assays that dominate the drug testing market. 
+Q.E.D. ® Saliva Alcohol Test 
+Our Q.E.D. ® saliva alcohol test is a point-of-care test device that is a cost-effective alternative to breath or blood alcohol testing. The test is a quantitative, saliva-based method for the detection of ethanol, has been cleared for sale by the FDA and has received a CLIA waiver. The U.S. Department of Transportation (“DOT”) has also approved the test. 
+5 
+Each Q.E.D. ® test kit contains a collection stick that is used to collect a sample of saliva and a disposable detection device that displays results in a format similar to a thermometer. The Q.E.D. ® device is easy to operate and instrumentation is not required to read the result. The product has a testing range of 0 to 0.145% blood alcohol and produces results in approximately two minutes. 
+Molecular Products and Services Segment 
+Genomic Products 
+We sell a number of genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA and/or RNA from human and animal biologic samples. Our lead products are sold under the Oragene ® and ORAcollect ® brands and are used to collect DNA from human saliva. These products are currently sold to thousands of academic research and commercial customers in many countries worldwide. 
+Our genomic products are available in several different configurations and contain proprietary chemical solutions that are optimized for the specific application for which each product is designed. Product physical design is focused on ease-of-use and reliability for self or assisted collection of samples. For example, several of the Oragene ® products require users to simply hold the product close to their mouth and spit into the collection device. When the container is closed, the reagents stored in the lid of the container are mixed with the captured saliva and immediately protect the nucleic acids in the sample. This non-invasive collection method yields nucleic acid that remains stable at ambient temperature for extended periods. The stabilizing technology results in high quality and high quantity nucleic acids that are required for most genetic testing and analysis methods. 
+We believe these products provide significant advantages over competing DNA and RNA collection methods such as blood collection or buccal swabs, particularly in human genetic applications. Benefits include the reliable collection of high-quality and stable genetic samples, use of simple non-invasive collection methods, the ability to store and transport collected samples for extended periods at ambient temperatures and compatibility with fully-automated laboratory testing systems. 
+We also sell the Colli-Pee ® collection device for the volumetric collection of first void urine samples. This product is used in liquid biopsy applications for the prostate and bladder cancer markets and in the sexually transmitted infection screening market. 
+Microbiome Products . 
+We also market several microbiome collection products designed to collect, stabilize and transport the microbial profile from multiple sample types. Unlike genomic DNA, the microbiome of a sample can change over time, especially when exposed to temperature and environment fluctuations. In order to optimize and standardize sample results, a reliable method that captures and preserves (“snapshots”) the microbiome after collection until analysis is required. We believe our products provide such a reliable method. 
+Our OMNIgene ® • GUT product is an all-in-one system designed to enable an individual to easily self-collect high quality microbial DNA from feces or stool samples for gut microbiome profiling for use in clinical laboratory and research settings. Current methodologies for gut microbiome profiling have distinct shortcomings due to the introduction of bias, leading to a lack of reproducibility in the field. Our product ensures that the fecal sample is fully stabilized immediately upon collection and maintains an accurate and reliable bacterial profile for weeks at room temperature. We have also begun marketing other microbiome collection kits for vaginal and oral samples. 
+Molecular Services . 
+Our molecular business also offers customers our GenoFIND TM services, a suite of genomic services that range from package customization and study design optimization to extraction, analysis and reporting services. Our GenoFIND TM offering has become an increasingly valuable tool for meeting the needs of our molecular customers. 
+Through our subsidiaries, CoreBiome and Diversigen, we also offer our customers microbiome laboratory testing and analytical services. CoreBiome provides its services with a focus on accelerating microbiome discovery for customers in the pharmaceutical, agriculture, and research communities, to unleash the translational potential of the microbiome. Through its proprietary BenchMark TM , BoosterShot TM , and Core Analysis TM platforms, CoreBiome provides fast and information-rich characterizations of microbial diversity and function paired with expert analytics. 
+Diversigen’s offering provides comprehensive microbiome and metagenomics services focused on solutions to improve human, animal and environmental health. Diversigen has extensive experience with highly diverse microbiome sample types and provides full project life cycle consulting services, including pre-project consulting, study design, extraction and sequencing to complete 
+6 
+bioinformatics analysis. Diversigen is at the forefront for setting quality standards for this industry and was the first company to establish microbiome protocols that comply with CAP accreditation and CLI A guidelines. We are in the process of integrating the services offered through GenoFIND TM , CoreBiome and Diversigen into a unified offering and brand for our customers. 
+Regulatory Approvals. 
+Our molecular collection products historically have been sold primarily as Class I medical devices for use by research and academic institutions. We have received FDA 510(k) clearance of the Oragene ® • DX product for use with the eSensor ® Warfarin sensitivity saliva test. A separate 510(k) clearance permits self-collection by consumers when the sample is to be tested with either an exempt or 510(k) cleared molecular test. More recently, we received a generic 510(k) clearance for this product, which we believe will further broaden the use of our Oragene ® • DX device. Our ORAcollect ® product similarly received 510(k) clearance from the FDA. We have also received CE mark approval for the Oragene ® • DNA, ORAcollect ® and OMNIgene ® • GUT collection kits. Both CoreBiome and Diversigen provide molecular services in CLIA-certified laboratories and as noted above, Diversigen’s laboratory protocols comply with CAP guidelines. 
+Products Under Development 
+Infectious Disease 
+Our research and development efforts include programs targeted at expanding and enhancing our infectious disease business. These programs primarily focus on products related to drug monitoring, rapid tests for diseases other than HIV and HCV and drug testing. A significant amount of effort in 2020 will be devoted to modifying our Intercept ® i2he collection device and optimizing the Thermo Fisher fully-automated oral fluid drug assays to meet the recently issued SAMSHA drug testing guidelines. Another development area is focused on increasing the number of country registrations for our HIV Self-Test and expanding our self-testing franchise to include other diseases such as HCV. Finally, we are looking at both internal and external opportunities to develop rapid point-of-care assays for drug adherence testing in the same markets where we currently sell our infectious disease diagnostic products. 
+Molecular Product and Services 
+In order to intersect evolving customer needs within the academic and commercial markets, our molecular business product development pipeline is focused on extending offerings across different sample types and analytes within both the genomics and microbiome areas. Genomic customers are demonstrating an increasing demand for RNA collection and stabilization. On the microbiome front, we continue to focus research and development work on collecting and stabilizing microbial DNA, RNA and metabolites from multiple sample types including gut, skin, vagina and saliva. We are also evolving the physical design and features of our products to further enable high throughput processing through improved interoperability with automated platforms. 
+The field of microbiome services is fast paced with evolving biological understanding and development of new methodologies. Our development efforts are focused on remaining at the forefront of technology, as well as providing new and relevant services to our customers. These development goals are being pursued while we also leverage new sequencing technologies and methodologies to enable scalability for our business. 
+Research and Development 
+Research and development expenses were $19.6 million in 2019, $16.3 million in 2018 and $13.4 million in 2017. These expenses include our costs associated with research and development, regulatory affairs, clinical trials and product support. 
+Sales and Marketing 
+We attempt to reach our major target markets through a combination of direct sales, strategic arrangements and independent distributors. Our marketing strategy is to create or raise awareness through a full array of marketing activities, which include trade shows, print advertising, special programs, distributor promotions, telemarketing and the use of digital and social media in order to stimulate sales in each target market. 
+7 
+We market our products in the United States and internationally. Consolidated net revenues attributable to customers in the United States were $ 107.3 million, $ 136.8 million and $121.5 million in 2019, 2018 and 2017 , respectively. Consolidated net revenues attributable to international customers amounted to $ 47.3 million, $ 44.9 million and $45.6 million , or 31 %, 25 % and 27% of our total revenues, in 2019, 2018 and 2017 , respectively. For more information about our revenues and long-lived assets attributable to U.S. and international customers, please see Note s 2 and 14 to our consolidated financial statements included elsewhere in this Annual Report. 
+Infectious Disease Testing - Professional 
+We market the OraQuick ADVANCE ® HIV-1/2 antibody test directly to customers in the public health market for HIV testing. This market consists of a broad range of clinics and laboratories and includes states, counties, and other governmental agencies, family planning clinics, colleges and universities, correctional facilities and the military. There are also a number of organizations in the public health market, such as AIDS service organizations and various community-based organizations that are set up primarily for the purpose of encouraging and enabling HIV testing. In the past, we sold our OraQuick ADVANCE ® test directly to hospitals in the U.S. through our internal sales force. We are now changing this approach to sell to hospitals primarily through distributors. We also use distributors to sell our OraQuick ADVANCE ® test into the U.S. physician office market and to retail clinics operated by pharmacies. In addition, we distribute our OraQuick ® HIV test in certain foreign countries through distributors. 
+Our OraQuick ® HCV test is sold primarily to the same markets where our OraQuick ® ADVANCE HIV test is sold, including public health organizations, hospitals, physicians and retail clinics. We also sell this test in other countries through distributors. 
+We initially sold our OraQuick ® Ebola test under an EUA and our only customer to date has been the CDC, which has purchased the product for field testing in Africa. There were approximately $200,000 of Ebola sales in 2019. Our ability to expand sales of this test to other customers will likely depend on the timing and extent of future outbreaks of the disease and the availability of government or other funding. We recently obtained FDA 510(k) clearance for this product and plan to request pre-qualification with the WHO. 
+We market the OraSure ® oral fluid collection device for HIV-1 testing, on its own and as a kit in combination with laboratory testing services. To better serve our public health customers, we have contracted a commercial laboratory to provide prepackaged OraSure ® test kits, with prepaid laboratory testing and specimen shipping costs included. 
+We also have distribution rights to an FDA 510(k) cleared and CLIA waived rapid flu A&B test, which we market under our proprietary OraSure QuickFlu ® tradename. Under our agreement with the supplier of this product, we are permitted to sell this product into the U.S. hospital and public health markets. 
+Infectious Disease Testing - OTC and Self-Test 
+We sell our OraQuick ® In-Home test in the U.S. retail or consumer market. Retailers carrying the product include CVS, Walgreens, Rite Aid and Walmart. The product is also available for purchase on-line through certain retailers and our website, www.oraquick.com . The primary target population for our HIV-OTC test comprises young, sexually active adults, with greater purchase intent found in high-risk sub-groups, such as men who have sex with men, African Americans and Latino Americans. 
+To support individuals that purchase and use our test, we offer toll-free customer support on a 24/7, 365-day per year basis. This service provides consumers with access to trained representatives who can answer questions about HIV/AIDS and the use of our test, and refer consumers to appropriate resources for follow-up confirmatory testing, counseling and medical treatment. 
+In 2016, we began selling our OraQuick ® HIV Self-Test to PSI (Population Services International) for use in a self-testing pilot program called the HIV Self-Testing in Africa, or STAR, project. Under Phase I of the project, our test was sold in three African countries, Malawi, Zambia and Zimbabwe. We were also selected to participate in Phase II of the project under which additional HIV Self-Tests were deployed. Although our participation in the STAR project has largely been completed, we registered our HIV Self-Test and continue to sell this product in other countries in Africa and elsewhere. 
+8 
+In June 2017, we entered into a C haritable S upport A greement with the Bill & Melinda Gates Foundation (“Gates Foundation”) that has enable d us to offer our OraQuick ® HIV Self-Test at an affordable price in 50 developing countries in Africa and Asia with funding from the Gates Foundation. The funding consist s of support payments tied to the volume of product we sell and reimbursement of certain related costs. The agreement has a four-year term and enable s non-governmental organizations in the eligible countries that receive funding from government or public sector agencies and donors to access our HIV Self - Test at reduced pricing. The funding from the Gates Foundation will be in an aggregate amount not to exceed $20.0 million over the four-year term or $6.0 million each year of the agreement. 
+In July 2017, our OraQuick ® HIV Self-Test was prequalified by the WHO. WHO prequalification aims to ensure that diagnostic tests for high burden diseases meet global standards of quality, safety, and efficacy in order to optimize use of health resources and improve health outcomes. WHO prequalification enables governmental organizations implementing HIV Self-Test pilots and programs to access international funding to purchase our test. 
+Substance Abuse Testing 
+Our substance abuse testing products are marketed to laboratories serving the workplace testing, forensic toxicology, criminal justice and drug rehabilitation markets in the U.S. and certain international markets. 
+We have entered into agreements for the distribution of our Intercept ® collection device and associated MICRO-PLATE assays for drugs-of-abuse testing in the workplace testing market in the United States and Canada through several laboratory distributors and internationally for workplace, criminal justice and forensic toxicology testing through other distributors. We also market the Intercept ® collection device on its own and as a kit in combination with laboratory testing services. To better serve our workplace customers, we have contracted with commercial laboratories to provide prepackaged Intercept ® test kits, with prepaid laboratory testing and specimen shipping costs included. 
+The criminal justice market in the United States for our substance abuse testing products consists of a wide variety of entities in the criminal justice system that require drug screening, such as pre-trial services, parole and probation offices, police forces, drug courts, prisons, drug treatment programs and community/family service programs. The forensic toxicology market consists of several hundred laboratories including federal, state and county crime laboratories, medical examiner laboratories and reference laboratories. 
+As discussed above, we also sell our next generation Intercept i2 ® collection device with a NIDA-5 panel of fully-automated high-throughput oral fluid assays developed with Thermo Fisher for the detection of PCP, THC, opiates, cocaine, methamphetamines and amphetamines. These products are currently sold into the criminal justice and drug treatment markets. Under an amendment to our Thermo Fisher agreement, we plan to obtain FDA 510(k) clearance of our Intercept i2 ® device for use with the NIDA-5 assay panel, along with an additional six fully-automated high-throughput assays in order to expand sales of this product line into the workplace testing market and other markets that require 510(k) cleared drug tests. These products are expected to meet recently issued oral fluid drug testing guidelines issued by SAMHSA, which will enable us to expand sales into markets where employee drug testing is federally regulated. We expect that the 510(k) cleared Intercept i2 ® device and related fully-automated high-throughput assays will eventually replace our original Intercept ® collector and MICRO-PLATE assays in the drug testing market. 
+We distribute our Q.E.D. ® saliva alcohol test primarily through various distributors in the United States and internationally. The markets for alcohol testing are relatively small and fragmented with a broad range of legal and procedural barriers to entry. Markets range from law enforcement testing to workplace testing of employees in safety sensitive occupations. Typical usage situations include pre-employment, random, post-accident, reasonable-cause and return-to-duty testing. 
+Insurance Risk Assessment 
+We currently market the OraSure ® oral fluid collection device for use in screening life insurance applicants in the United States and internationally to test for three of the most important underwriting risk factors: HIV-1, cocaine and cotinine (a metabolite of nicotine). Devices are sold to insurance testing laboratories, which in turn sell the devices to insurance companies, usually in combination with testing services. 
+We also promote use of the OraSure ® device directly to insurance companies for life insurance risk assessment. Insurance companies then make their own decision regarding which laboratory to use to supply their collection devices and testing services. 
+There exists a wide range of policy limits where our OraSure ® product is being used. In general, many (but not all) of our insurance company customers use the OraSure ® device in connection with life insurance policies having face amounts of up to $250,000, with some customers using the device for policies of up to $500,000 in amount. Some insurance companies have chosen to extend their 
+9 
+testing to lower policy limits where they did not test at all before, while others have used OraSure ® to replace some of their blood and urine-based testing. In recent years, some insurance customers have adopted a “Simplified Issues” policy, where lab testing is no longer required and instead the applicant completes a questionnaire about personal behaviors. 
+We also sell our AUTO-LYTE ® assays and reagents in the insurance testing market directly to certain laboratories. 
+Molecular Products and Services 
+DNAG sells its products directly to its customers, primarily through its own internal sales force. In many international markets, distributors are used. 
+Most of DNAG’s revenues are derived from product sales to commercial customers and into the academic and research markets. Sales to commercial customers providing consumer genetics and clinical diagnostic services have been increasing and account for a majority of DNAG’s revenues. A significant portion of DNAG’s sales are derived from repeat customers, in both markets. DNAG also has customers in the livestock and companion animal markets. 
+DNAG has expanded its market focus by developing new collection devices for the emerging microbiome market, which is focused on the study of microbes and their effect on human health. DNAG’s primary product offering in the microbiome market, OMNIgene ® • GUT, is focused on the human gut microbiome (microbes living in human stool). DNAG is leveraging its existing sales force and global research connections to engage microbiome customers around the world to establish itself as the leader in ease-of-collection, stabilization and transport of this challenging sample type. 
+During 2019, we began selling the Colli-Pee ® device for the volumetric collection of first void urine, as a result of our acquisition of Novosanis. This product is in its early stages and initial sales are occurring primarily through distributors and collaborations for use in the liquid biopsy and sexually transmitted disease markets. 
+DNAG is also offering laboratory and analytical services for both genomics and microbiome customers in order to more fully meet the needs of its customers. These services are primarily provided to pharmaceutical and biotech companies and research institutions. During 2019, we substantially expanded our ability to offer microbiome laboratory and bioinformatics services with the acquisition of CoreBiome and Diversigen. We expect to integrate the laboratory operations of CoreBiome and Diversigen so that we can provide a single-integrated offering to our customers. 
+Significant Products and Customers 
+Several different products have contributed significantly to our financial performance, accounting for 10% or more of our total revenues during the past three years. The table below shows a breakdown of those product revenues (dollars in thousands). 
+For the years ended December 31, 
+2019 
+2018 
+2017 
+Oragene ® 
+$ 
+46,701 
+$ 
+69,798 
+$ 
+67,232 
+OraQuick ® HIV 
+43,092 
+41,457 
+35,148 
+OraQuick ® HCV 
+12,972 
+12,394 
+25,409 
+One of our customers accounted for approximately 15%, 24% and 25% of our net consolidated revenues in 2019, 2018 and 2017, respectively. 
+Supply and Manufacturing 
+Our OraQuick ADVANCE ® HIV test, OraQuick ® In-Home HIV test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® collection devices, AUTOLYTE and MICRO-PLATE assays and QED ® saliva alcohol test are all manufactured in our Bethlehem, Pennsylvania facilities. We expect to continue to manufacture these products at this location for the foreseeable future. 
+We have contracted with a third party in Thailand for the assembly of the OraQuick ® HIV device and the OraQuick ® HIV Self-Test in order to supply certain international markets. This supply agreement had an initial term of one year, and automatically renews for additional annual periods unless either party provides a timely notice of termination prior to the end of an annual period. We believe that other firms would be able to assemble these OraQuick ® tests on terms no less favorable than those set forth in the agreement if the Thailand contractor would be unable or unwilling to continue assembling this product. 
+10 
+We can purchase the HIV antigens, the nitrocellulose and certain other critical components , and the HCV and Ebola antigens used in our OraQuick ® product lines only from a limited number of sources. If for any reason these suppliers are unwilling or no longer able to supply our antigen or nitrocellulose needs, we believe that alternative supplies could be obtained at a competitive cost. However, a change in any of the antigens, the nitrocellulose or other critical components used in our products would require FDA approval and some additional development work. This in turn could require significant time to complete, increase our costs and disrupt our ability to manufacture and sell the affected products. 
+Our MICROPLATE and AUTO-LYTE assays require the production of highly specific and sensitive antibodies corresponding to the antigen of interest. Substantially all our antibody requirements are provided by contract suppliers. We believe that we have adequate reserves of antibody supplies and that we have access to sufficient raw materials for these products. 
+Our OraSure QuickFlu ® test is manufactured and supplied under a private label agreement with a third party. There is no other supply source for this product. 
+The fully-automated high-throughput oral fluid drug assays sold with our new Intercept i2 ® collection device are manufactured and supplied under a long-term agreement with Thermo Fisher. There is no other supply source for these products. 
+DNAG has two long-term contract manufacturing relationships to supply virtually all of its products, including the Oragene ® product line. Many of the raw materials and components used in these products are also purchased from third parties, including one critical component that is purchased from a sole source supplier. We believe there are other suppliers that can manufacture and supply the raw materials and components for the DNAG products. 
+Our Colli-Pee ® device is currently manufactured at our Belgian assembly facility with components supplied by third party vendors. 
+Our GenoFIND TM genomics laboratory services are provided to our customers by a third party laboratory. We believe there are other laboratories that can also provide these services. Our microbiome laboratory testing and analytical services are provided by our subsidiaries, CoreBiome and Diversigen. 
+Employees 
+As of December 31, 2019, we had 472 full-time employees. Of this total, there were 139 in sales, marketing and client services; 58 in research and development; 187 in operations, manufacturing, quality control, information systems, purchasing and shipping; 44 in quality assurance and regulatory affairs; and 44 in administration and finance. This compares to 398 employees as of December 31, 2018. Our employees are not currently represented by a collective bargaining agreement. 
+Competition 
+OSUR Segment 
+The diagnostic industry is a multi-billion dollar international industry and is intensely competitive. Many of our competitors are substantially larger than we are, and have greater financial, research, manufacturing and marketing resources than we do. 
+The primary competitive factors for our products include price, quality, performance, ease of use, customer service and reputation. Industry competition is based on these and the following additional factors: 
+• 
+Scientific and technological capability; 
+• 
+Proprietary know-how; 
+• 
+The ability to develop and market products and processes; 
+• 
+The ability to obtain FDA or other regulatory approvals; 
+• 
+The ability to manufacture products that meet applicable FDA or other applicable regulatory requirements; 
+• 
+Commercial execution and strength of distribution; 
+• 
+Access to adequate capital; 
+• 
+The ability to attract and retain qualified personnel; and 
+• 
+The availability of patent protection. 
+11 
+A few large corporations produce a wide variety of diagnostic tests and other medical devices and equipment. A larger number of mid-size companies generally compete only in the diagnostic industry and a significant number of small companies produce only a few diagnostic products. As a result, the diagnostic test industry is highly fragmented and segmented. 
+The future market for diagnostic products is expected to be characterized by greater cost consciousness, the development of new technologies, tighter reimbursement policies and consolidation. The purchasers of diagnostic products are expected to place increased emphasis on lowering costs, reducing inventory levels, obtaining better performing products, automation, service and volume discounts. The increased complexity of the market is expected to force many competitors to enter into joint ventures or license certain products or technologies. 
+We expect competition to intensify as technological advances are made and become more widely known, and as new products reach the market. Furthermore, new testing methodologies could be developed in the future that render our products impractical, uneconomical or obsolete. There can be no assurance that our competitors will not succeed in developing or marketing technologies and products that are more effective than those we develop or that would render our technologies and products obsolete or otherwise commercially unattractive. In addition, there can be no assurance that our competitors will not succeed in obtaining regulatory approval for these products, or introduce or commercialize them, before we can do so. These developments could have a material adverse effect on our business, financial condition and results of operations. 
+Several companies market or have announced plans to market oral specimen collection devices and tests both within and outside the United States. We expect the number of devices competing with our OraQuick ® , OraSure ® , Intercept ® and Intercept i2 ® devices to increase as the benefits of oral fluid-based testing become more widely accepted. 
+Competition in the U.S. market for infectious disease testing in medical settings is intense and is expected to increase. Our principal competition for HIV testing in the professional market comes from existing and new point-of-care rapid blood tests, automated laboratory-based blood tests, or other oral fluid-based tests. Our competitors sell both a rapid oral fluid HIV test and a rapid HIV antigen/antibody test that are both FDA approved and CLIA waived. Our OraQuick ® rapid HCV test competes against laboratory-based blood tests in the U.S., as there currently are no other rapid HCV testing products approved by the FDA. 
+Our competitors in the domestic infectious disease testing market include medical diagnostic companies and specialized biotechnology firms, as well as pharmaceutical companies with biotechnology divisions. Competing tests are often sold at a lower price than we charge for our products. This competition can result in lost sales and degradation of the price (and therefore the applicable profit margins) we can charge for our HIV and HCV tests. 
+Outside the U.S., our rapid HIV and HCV tests compete against other rapid and laboratory-based tests. Significant sales of these products in Europe have not materialized principally because of differences in European healthcare systems compared to U.S. systems. Unlike in the U.S., adoption of rapid point-of-care diagnostics is not widespread in Europe because laboratory testing is entrenched and healthcare systems are structured around centralized testing models. In addition, many competing tests in international markets are sold at very low prices. We intend to continue to build awareness and develop strategies to expand sales of our OraQuick ® HIV and HCV tests in European and other international markets. 
+Our OraQuick ® In-Home HIV oral fluid test is the only rapid HIV test approved by the FDA for sale in the U.S. OTC market. We compete against one other non-rapid HIV blood test available in the OTC market, which requires consumers to self-collect a blood sample and then send it to a laboratory for testing. We expect that other non-rapid HIV blood tests will eventually compete with our product. The OraQuick ® HIV Self-Test that we sell in certain international markets is facing competition from other blood-based rapid HIV self-tests. 
+Competition for our OraQuick ® Ebola test includes government and commercially-developed laboratory and point-of-care molecular tests, along with a small number of rapid antigen tests sold under an FDA EUA. Our Ebola test is the only product with FDA 510(k) clearance for use on both whole blood samples from living patients and oral fluid samples from cadavers. 
+The OraSure QuickFlu ® test competes primarily against other rapid flu tests sold by various third parties in the U.S. hospital and public health markets. 
+In the substance abuse testing market, our Intercept ® drug testing system competes with laboratory-based drug testing products using sample matrices such as urine, hair, sweat and oral fluid. We expect competition for our products to intensify, particularly from other domestic and international companies that have developed, or may develop, competing oral fluid drug testing products. 
+There are at least two competitors that sell fully-automated high-throughput oral fluid drug testing products in unregulated settings in the United States. These competitors sell these assays for use with either their own oral fluid collector or a collector manufactured by another party. These offerings compete against our Intercept ® and Intercept i2 ® collection devices and related oral fluid assays. 
+12 
+Our MICRO-PLATE oral fluid drug assays, which are sold for use with the original Intercept ® collector and our OraSure ® collection device, also continue to come under increasing competitive pressure from “home-brew” assays developed internally by our laboratory customers. Our oral fluid MICRO-PLATE assays also compete with urine-based homogeneous assays that are run on fully-automated, random access analyzers. These tests provide strong competitive pressure because they provide the benefits of automation, including lower costs and short turn-around times. 
+Our MICRO-PLATE drugs-of-abuse reagents sold in the forensic toxicology market are targeted to forensic testing laboratories where sensitivity, automation and “system solutions” are important. In the past, these laboratories have typically had to rely on radioimmunoassay test methods to provide an adequate level of sensitivity. Radioimmunoassays require radioactive materials, which have a short shelf-life and disposal problems. Our MICRO-PLATE tests meet the laboratories’ sensitivity needs, run on automated equipment, are not radioimmunoassays, and are offered to the laboratory as a complete system solution of reagents, instrumentation and software to meet the specific needs of each customer. We compete with both homogeneous and heterogeneous tests manufactured by many companies. 
+Sales of our AUTO-LYTE ® urine assays have declined substantially over a number of years, primarily due to competition from “home-brew” assays developed internally by our laboratory customers, which can be produced at a cost lower than the price typically paid for our products. Many of our customers no longer purchase our AUTO-LYTE ® assays, and we may eventually stop selling this product line. 
+Q.E.D. ® competes against other semi-quantitative saliva-based alcohol tests that have received U.S. Department of Transportation approval as well as breath alcohol tests. Although there are lower priced tests on the market that use oral fluid or breath as a test medium, these tests are qualitative tests that are believed to be substantially lower in quality and provide fewer benefits than our Q.E.D. ® test. 
+Molecular Products and Services 
+Our Oragene ® and ORAcollect ® collection systems compete against other types of collection devices used for molecular testing, such as blood collection devices and buccal swabs, which often are sold for prices lower than the prices charged for the Oragene ® and ORAcollect ® products. Although we believe the Oragene ® and ORAcollect ® devices offer a number of advantages over these other products, the availability of lower price competitive devices can result in lost sales and degradation in pricing and profit margin. Our Oragene ® and ORAcollect ® products are also facing increasing competition from similarly designed collection systems which are beginning to enter the market. 
+OMNIgene ® • GUT is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions developed by various researchers, including simply freezing the sample after collection. The microbiome market is expected to require standardization in the methods used for collection and stabilization in order to derive more accurate and repeatable results. To date, DNAG is one of the few vendors to offer a solution that fully meets these requirements. 
+Our genomic and microbiome laboratory service offerings primarily compete against a number of commercial reference laboratories, specialty laboratories and hospital laboratories in the U.S. 
+Patents and Proprietary Information 
+We seek patents and other intellectual property rights to protect and preserve our proprietary technology and our right to capitalize on the results of our research and development activities. We also rely on trade secrets, know-how, continuing technological innovations and licensing opportunities to provide competitive advantages for our products in our markets and to accelerate new product introductions. We regularly search for third-party patents in fields related to our business to shape our own patent and product commercialization strategies as effectively as possible and to identify licensing opportunities. United States patents generally have a maximum term of 20 years from the date an application is filed. 
+We have four United States patents and numerous foreign patents for the OraSure ® and Intercept ® collection devices and technology relating to oral fluid collection, containers for oral fluids, methods to test oral fluid, formulations for the manufacture of synthetic oral fluid, and methods to control the volume of oral fluid collected and dispersed. The U.S. patents expire from November 2021 to December 2026. We have also applied for additional patents, in both the United States and certain foreign countries, on such products and technology. 
+We have one United States patent for our OraQuick ® platform expiring in 2028, as well as corresponding related international patents. We also have patent applications pending internationally. 
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+We hold, through our subsidiary, DNAG, twenty United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues. These patents expire from February 2022 through March 2035 . 
+We hold through our subsidiary, Novosanis, two United States patents and numerous foreign patents covering a medical device for capturing a predetermined volume of first void urine and an intradermal injection device for accurate injection of small volumes of drugs in the skin. These patents expire from April 2034 through April 2035. 
+Our subsidiary, CoreBiome, has licensed one United States patent and several foreign patent applications from the University of Minnesota for analytical standards to detect and/or measure sampling, processing, and/or amplification errors in a biological samples containing polynucleotide molecules. This license also covers certain software and know-how related to laboratory and bioinformatics procedures and processes. 
+Our subsidiary, Diversigen, has licensed certain know-how and database assets from the Baylor College of Medicine related to laboratory processes for microbiome and metagenomics services. 
+We require our employees, consultants, outside collaborators and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed by or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees and certain consultants, the agreements also provide that all inventions conceived by the individual during his or her tenure with us or the performance by the consultant of services for us will be our exclusive property. 
+We own rights to trademarks and service marks that we believe are necessary to conduct our business as currently operated. In the United States, we own a number of trademarks, including the OraSure ® , Intercept ® , Intercept i2 ® , OraQuick ® , OraQuick ADVANCE ® , OraSure QuickFlu ® , Q.E.D. ® , Oragene ® , ORAcollect ® , OMNIgene ® , Diversigen ® , Colli-Pee ® , VAX-ID ® , AUTO-LYTE ® , prepIT ® and Hemagene ® trademarks. We also own many of these marks and others in several foreign countries and we are pursuing registration of several other trademarks. 
+Although important, the issuance of a patent or existence of trademark or trade secret protection does not in itself ensure the success of our business. Competitors may be able to produce products competing with our patented products without infringing our patent rights. Issuance of a patent in one country generally does not prevent manufacture or sale of the patented product in other countries. The issuance of a patent is not conclusive as to validity or as to the enforceable scope of the patent. The validity or enforceability of a patent or trademark can be challenged by litigation after its issuance or registration. If the outcome of such litigation is adverse to the owner of the patent, the owner’s rights could be diminished or withdrawn. Trade secret protection does not prevent independent discovery and exploitation of the secret product or technique. 
+Government Regulation 
+General 
+Most of our products are regulated by the U.S. Food and Drug Administration (“FDA”), along with other federal, state and local agencies and comparable regulatory bodies in other countries. This regulated environment governs almost all aspects of development, production and marketing, including product design and testing, authorizations to market, labeling, advertising and promotion, manufacturing, distribution, post-market surveillance and reporting, and recordkeeping. We believe that our products and procedures are in material compliance with all applicable regulations, but the regulations regarding the manufacture and sale of our products may be unclear and are subject to change. We cannot predict the effect, if any, that these changes might have on our business, financial condition or results of operations. 
+Many of our FDA-regulated products require some form of review and action by the FDA before they can be marketed in the United States. After approval or clearance by the FDA, we must continue to comply with other FDA requirements applicable to marketed products and are subject to periodic inspections by the FDA and other regulatory bodies. Both before and after approval or clearance, failure to comply with the FDA’s requirements can lead to significant penalties or could disrupt our ability to manufacture and sell these products. In addition, the FDA could refuse permission to obtain certificates needed to export our products if the agency determines that we are not in compliance. 
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+Domestic Regulation 
+Most of our products are regulated in the United States as in vitro diagnostic and medical devices. 
+There are several mechanisms by which regulated devices can be placed on the market in the United States. Some products may qualify for clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act. To obtain this clearance from the FDA, the manufacturer must submit to the FDA a premarket notification that it intends to begin marketing the product, and show that the product is substantially equivalent to another legally marketed predicate device (i.e., a device that has been cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976; a device that has been downclassified by the FDA; or a device that FDA has previously determined to be exempt from the 510(k) process). To be substantially equivalent, an applicant must show that when compared to a predicate, the new device has the same intended use and same technology, or if different technology, that the new device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness. In all cases, data from some form of performance testing is required and in some cases, the submission must include data from human clinical studies. An applicant must submit a 510(k) application at least 90 days before commercial distribution of the affected product commences. Marketing may only commence when the FDA issues a clearance letter finding that the new device is substantially equivalent to the predicate device. The standards and data requirements necessary for the clearance of a new device may be unclear or may be subject to change. Although FDA clearance usually takes from four to twelve months, in some cases more than a year may be required before clearance is obtained, if at all. 
+If the device does not qualify for the 510(k) procedure, either because there is no existing predicate device, it is not substantially equivalent to a legally marketed predicate device or because it is classified by the FDA as a high risk device, the FDA must approve either a request for de novo classification or a premarket approval application, or PMA, before marketing can begin. A de novo classification is an alternate pathway to classify novel devices of low to moderate risk for which no substantially equivalent predicate device exists. Clearance of a de novo request generally takes 150 days from the time of submission of the de novo request, although it can take longer. PMAs are generally required for devices that are determined to be high risk and must demonstrate, among other matters, that the medical device provides a reasonable assurance of safety and effectiveness for the intended use(s) of the device. A PMA is typically a complex submission, supported by valid scientific evidence, including the results of preclinical and clinical studies, usability data, detailed information about the manufacturing process for the device, and other data and information. Preparing a PMA is a resource-intensive and time-consuming process. Once a PMA has been submitted, the FDA is required to review the submission within 180 days. However, the FDA’s review may be, and often is, much longer, in many cases requiring one to three years or more, and may include requests for additional data, review by an independent panel of experts, and facility inspections before approval is granted, if at all. 
+If the FDA approves the PMA, it may place restrictions on the device. If the FDA’s evaluation of the PMA or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter. The FDA may also require additional clinical trials, which can delay the PMA approval process by several years or prevent a PMA approval from being obtained. 
+If the FDA discovers that an applicant has submitted false or misleading information in any application or notification, the FDA may take action against the applicant and its employees or refuse to review submissions until certain requirements are met pursuant to its Application Integrity Policy (AIP). Delays in receipt of or failure to receive such clearances or approvals, the loss of previously received clearances or approvals, or the failure to comply with existing or future regulatory requirements could have a material adverse effect on our business, financial condition and results of operations. 
+If there are any modifications made to our marketed devices, a new premarket notification or PMA supplement may be required to be submitted to, and approved by, the FDA, before the modified device may be marketed. A new PMA or a PMA supplement is required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to the device’s intended use(s), manufacturing process, manufacturing facility, critical components, labeling and design. Likewise, a new 510(k) clearance is required for any modification that could significantly affect the safety or effectiveness of the device, e.g. a significant change or modification in design, material, chemical composition, energy source, or manufacturing process or a major change or modification in the intended use(s) of the device. 
+A clinical trial may be required in support of a 510(k) submission and generally is required for a de novo or PMA application. These trials generally require an Investigational Device Exemption, or IDE, application approved in advance by the FDA for a specified number of patients, unless the proposed study is deemed to be exempt from the IDE requirements. In addition, if a study meets the requirements for a non-significant risk study, it may be eligible for compliance with “abbreviated” IDE requirements, which include a subset of the requirements applicable to significant risk medical device studies. If a full IDE is required, an IDE application must be supported by appropriate data, such as laboratory testing results, protocols for the proposed investigation, and other information demonstrating that the device is appropriate for use with humans in a clinical study. Clinical trials may begin if the IDE application is 
+15 
+approved by the FDA and the appropriate institutional review boards, or IRBs, at the clinical trial sites. Submission of an IDE application does not give assurance that the FDA will issue the IDE. If the IDE application is approved, there can be no assurance the FDA will determine that the data derived from the trial(s) support the ultimate approval or clearance of the device or warrant the continuation of clinical trials. An IDE supplement must be submitted to and approved by the FDA before a sponsor or investigator may make a change to the investigational plan in such a way that may affect its scientific soundness, study indication or the rights, safety or welfare of human subjects. The trial must also comply with the FDA’s regulations, including the requirement that informed consent be obtained from each subject, and with clinical trial reporting regulations that require submission of information on certain clinical trials to a database maintained by the National Institutes of Health. Even if a trial is completed, the results of clinical testing may not adequately demonstrate the safety and efficacy of the device or may otherwise not be sufficient to obtain FDA clearance to market the product in the United States. 
+Some of our products are used for research only or other nonclinical or non-diagnostic purposes. Our molecular collection products are sold to many academic and research institutions for research purposes and our drugs-of-abuse products are sold to laboratories and clinics for forensic or other non-medical uses. The FDA does not currently regulate products used for these purposes, although other state and federal regulatory requirements may apply. 
+Another option for marketing a product in the U.S. is through an EUA that is granted by the FDA as a result of the Secretary of Health and Human Services declaring an emergency justifying the authorization of emergency use of certain in vitro diagnostic devices to aid in addressing the emergency. Typically, analytical and clinical studies are completed as required by the FDA. Products are exempt from design controls and other quality requirements in order to expedite development of diagnostic tools to aid in the diagnosis of viral pathogens that have the potential to affect public health. 
+Most devices distributed in the United States must comply with the FDA’s Quality System Regulations (“QSRs”), including current good manufacturing practices. These regulations govern the entire lifecycle of a medical device, including design, manufacture, testing, release, packaging, distribution, documentation and purchasing as well as complaint handling, corrective and preventative actions, and internal auditing. In complying with the QSRs, manufacturers must continue to expend time, money and effort in the area of production, quality, and postmarket surveillance to ensure full compliance. 
+Companies are also subject to other post-market and general requirements, including product listing and establishment regulations, which help facilitate FDA inspections and other regulatory action, post-market surveillance requests, restrictions imposed on marketed products, promotional standards and requirements for recordkeeping and reporting of certain adverse reactions and malfunctions. Device reporting regulations require that manufacturers report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur. 
+The FDA regularly inspects companies to determine compliance with the QSRs and other post-market requirements. Failure to comply with statutory requirements and the FDA’s regulations can result in an FDA Form 483 (which is issued by the FDA at the conclusion of an inspection when an investigator has observed any conditions that may constitute violations), public warning letters, monetary penalties against a company or its officers and employees, suspension or withdrawal of regulatory approvals, operating restrictions, total or partial suspension of production, injunctions, product recalls, product detentions, refusal to provide export certificates, seizure of products and criminal prosecution. We believe that our facilities and procedures are in material compliance with the FDA’s OSR regulations and other postmarket requirements, but the regulations are subject to change or may be unclear, and we cannot be sure that FDA investigators will agree with our compliance with the FDA’s postmarket requirements. 
+The Clinical Laboratory Improvement Amendments of 1988, or CLIA, prohibit any facility that conducts laboratory testing on specimens derived from humans from providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of human beings, unless there is in effect for such facility a certificate issued by the U.S. Department of Health and Human Services applicable to the category of examination or procedure performed. Tests may be waived from this regulatory oversight if they meet certain requirements established under CLIA. We consider the applicability of CLIA requirements in the design and development of our products. We have obtained a waiver of the CLIA requirements for our OraQuick ADVANCE ® rapid HIV-1/2 antibody test, our OraQuick ® HCV rapid antibody test and our Q.E.D. ® alcohol saliva test and may seek similar waivers for certain other products. In addition, the supplier of the OraSure Quick-Flu ® test has obtained a CLIA waiver for that product. A CLIA waiver allows certain customers to use the waived products that may not have been able to use them without complying with applicable quality control and other requirements. 
+The laboratory services provided by our subsidiaries, CoreBiome and Diversigen, operate under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and consist of microbiome and metagenomics sequencing, bioinformatics and analysis. CoreBiome has recently received a CLIA certificate of registration in Minnesota and Diversigen operates under the Baylor College of Medicine CLIA certificate of compliance and CAP accreditation. A CLIA certificate of compliance is issued once a state regulator or the Center 
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+for Medicare and Medicaid Services determines that the laboratory is compliant with the applicable CLIA requirements. CAP accredits laboratories performing testing on specimens from human beings or animals, using methodologies and clinical applications within the expertise of the laboratory accreditation program. 
+Certain of our products may also be affected by state regulations in the United States, which can restrict the use and sale of certain diagnostic products. We are presently working with legislators or regulators in certain of these states in an effort to modify or remove any restrictions affecting our ability to sell products. 
+Advertising and Promotion 
+Advertising and promotion of medical devices, in addition to being regulated by the FDA, are also regulated by the Federal Trade Commission (“FTC”) and by other federal and state regulatory and enforcement authorities, including the Department of Justice (“DOJ”), the Office of Inspector General of the Department of Health and Human Services, and various state attorneys general. Although physicians are permitted to exercise medical judgment to use medical devices for indications other than those cleared or approved by the FDA, we may not promote our products for such “off-label” uses and can only market our products for cleared or approved uses. Promotional activities for FDA-regulated products of other companies have also been the subject of enforcement actions brought under healthcare reimbursement laws and consumer protection statutes. In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims. If the FDA determines that our promotional materials or training constitute promotion of an uncleared or unapproved use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a notice of violation, a warning letter, injunction, seizure, civil fine or criminal penalties. FTC enforcement actions often result in consent decrees that constrain future actions. DOJ prosecutions can result in significant criminal and civil penalties, including exclusion from the Medicare and Medicaid programs. If an enforcement action is brought by the FDA or FTC, our reputation could be damaged and sales of our products could be impaired. 
+Import and Export Requirements 
+Products for export from the United States are subject to foreign countries’ import requirements and the exporting requirements of the FDA, as applicable. In particular, international sales of medical devices manufactured in the United States that are not approved or cleared by the FDA for use in the United States, or are banned or deviate from lawful performance standards, are subject to FDA export requirements. 
+Foreign countries often require, among other things, an FDA certificate for products for export, also called a Certificate for Foreign Government (“CFG”). To obtain this certificate from the FDA, the device manufacturer must apply to the FDA. The FDA certifies that the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with QSR regulations at the time of the last FDA inspection. If the FDA determines that our facilities or procedures do not comply with the QSR regulations, it may refuse to provide such certificates until we resolve the issues to the FDA’s satisfaction. Failure to obtain a CFG could inhibit our ability to export our products to countries that require such certificates. 
+International 
+We are also subject to regulations in foreign countries governing products, human clinical trials and marketing, and may need to obtain approval (or pre-qualification or endorsement) from international public health agencies, such as the World Health Organization, in order to sell products in certain countries. Approval processes vary from country to country, and the length of time required for approval or to obtain other clearances may in some cases be longer than that required for U.S. governmental approvals. We generally pursue approval only in those countries that we believe have a significant market opportunity. 
+The International Organization for Standardization (“ISO”) is a worldwide federation of national standards bodies from some 130 countries, established in 1947. The mission of the ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services. ISO certification indicates that our quality system complies with standards applicable to activities ranging from initial product design and development through production and distribution. 
+In the European Union (“EU”), products that fall under the scope of the Medical Devices Directive (“MDD”) and the In Vitro Diagnostic Directive (“IVDD”) are not subject to the prior approval of a regulatory authority, but, depending on the class of product, may require prior review by a notified body. Notified bodies are accredited and supervised by national regulatory authorities to conduct conformity assessment procedures of medical devices or other products. Such products must comply with certain essential requirements listed in those directives. ISO certification creates a rebuttable presumption that the product satisfies the applicable 
+17 
+requirements. Compliance with these requirements allows us to complete the applicable conformity assessment procedure, involving a notified body where necessary, and to affix the CE mark to our products, without which they may not be placed on the market in the EU. 
+In addition, the EU has adopted the EU Medical device Regulation (the “EU MDR”) and the In Vitro Diagnostic Regulation (the “EU IVDR”), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance. Manufacturers of currently approved medical devices will have until May 2020 to meet the requirements of the EU MDR and until May 2022 to meet the EU IVDR. Compliance with these regulations may be expensive and time-consuming. Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements. 
+We have completed the applicable conformity assessment procedures and obtained the right to use the CE mark for the OraQuick ADVANCE ® HIV-1/2 test, OraQuick In-Home HIV Test, the OraQuick ® HCV test and certain of the Oragene ® collection kits and OMNIgene ® products sold by DNAG and the Colli-Pee ® first-void urine collection devices manufactured and sold by Novosanis. 
+We must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in Canada. We have completed this process for several of our current products and may do so with respect to other products in the future. In addition, Canadian law requires manufacturers of medical devices to have a quality management system that meets various ISO requirements in order to obtain a license to sell their devices in Canada. Health Canada also requires all companies that market Class II, Class III and Class IV products in Canada to be certified as part of the Medical Device Single Audit Program (MDSAP). We received this certification for our OSUR segment in June 2019. 
+We have obtained WHO pre-qualification for our OraQuick ® HIV Self-Test and OraQuick ® HCV test and we will likely seek WHO pre-qualification or endorsement for certain other products sold into international markets. 
+Anti-Kickback and Other Fraud and Abuse Laws 
+The Federal Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation, or receipt of any form of remuneration in return for, or to induce: 
+• 
+The referral of an individual to a person for the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other governmental healthcare programs; or 
+• 
+The purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of any item or service reimbursable under Medicare, Medicaid, or other governmental healthcare programs. 
+Our products are or may be purchased by customers that will seek or receive reimbursement under Medicare, Medicaid or other governmental healthcare programs. Noncompliance with the federal anti-kickback statute can result in exclusion from Medicare, Medicaid or other governmental healthcare programs, and/or restrictions on our ability to operate in certain jurisdictions, as well as civil and criminal penalties, any of which could have an adverse effect on our business and results of operations. 
+The Federal Civil Monetary Penalties Law prohibits the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services. Noncompliance can result in civil monetary penalties for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion from the Federal healthcare programs. 
+Many states have also adopted some form of anti-kickback laws. A determination of liability under such laws could result in fines and penalties, restrictions on our ability to operate in these jurisdictions and significant damage to our reputation. 
+We are also subject to other federal and state laws targeting fraud and abuse in the healthcare industry, including false claims laws, marketing conduct laws and laws constraining the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements, including sales programs, such manufacturers can enter into with physicians, hospitals, laboratories and other potential purchasers of medical devices. Violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in government healthcare programs such as Medicare and Medicaid. These laws and regulations are wide ranging and subject to changing interpretation and application. In recent years, there has been greater scrutiny of marketing practices in the medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical 
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+device manufacturers of payments to certain healthcare professionals and providers. For example, under the Sunshine Act provisions of the Affordable Care Act, device manufacturers are subject to new federal reporting and disclosure requirements with regard to payments or other transfers of value made to physicians and teaching hospitals. Reports submitted under the Sunshine Act are placed in a public database. Device manufacturers are required to submit annual reports by March 31 which cover the prior calendar year. To be in compliance with such disclosure laws, we have implemented necessary systems to accurately track gifts and other payments. 
+We have implemented a written Policy on Interactions with Health Care Professionals, which is based on the Code of Conduct for Interactions with Health Care Professionals promulgated by the Advanced Medical Technology Association, or AdvaMed, a leading trade association representing medical device manufacturers. The Policy applies to all employees and is intended to comply with applicable state and federal laws, regulations and government guidance. The Policy addresses interactions related to sales and marketing practices, research and development, product training and education, grants and charitable contributions, support of third-party educational conferences, and consulting arrangements. While we believe that our practices are in compliance with the Anti-Kickback and other fraud and abuse laws, the standards for compliance with such statutes can be unclear and subject to change. 
+Foreign Corrupt Practices Act and Other Anti-Corruption Laws 
+The U.S. Foreign Corrupt Practices Act (“FCPA”) prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity. It is illegal to use any means of interstate commerce corruptly in the furtherance of any offer, payment, promise to pay or authorization of payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. Our present and future business has and will continue to be subject to the FCPA and various other laws, rules and/or regulations applicable to us as a result of our international sales. Those laws include the U.K. Bribery Act (the “Bribery Act”), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official, and failing to have adequate procedures to prevent employees and other agents from giving bribes. U.S. companies that conduct business in the United Kingdom generally will be subject to the Bribery Act. Penalties under the Bribery Act include potentially unlimited fines for companies and criminal sanctions for corporate officers under certain circumstances. 
+Environmental Regulation 
+Because of the nature of our current and proposed research, development, and manufacturing processes, we are subject to stringent federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge and handling and disposal of solid wastes, hazardous materials and hazardous wastes. Products that we sell in Europe are subject to regulation in European Union, or EU, markets under the Restriction of the Use of Hazardous Substances Directive, or RoHS. RoHS prohibits companies from selling products which contain certain hazardous materials, including lead, mercury, cadmium, chromium, polybrominated biphenyls and polybrominated diphenyl ethers, in EU member states. In addition, the EU’s Registration, Evaluation, Authorization, and Restriction of Chemicals Directive also restricts substances of very high concern in products. 
+Future environmental laws may require us to alter our manufacturing processes, thereby increasing our manufacturing costs. We believe that our products and manufacturing processes at our facilities comply in all material respects with applicable environmental laws and worker health and safety laws; however, the risk of environmental liabilities cannot be completely eliminated. 
+The foregoing discussion of our business should be read in conjunction with the consolidated financial statements and accompanying notes included in Item 15 of this Annual Report. 
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+ITEM 13. 
+Certain Relationships and Related Transactions, and Director Independence. 
+The information required by this Item is incorporated by reference to the information under the captions “Transactions with Related Persons” and “Corporate Governance - Director Independence” in the Proxy Statement.

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+ITEM 9A. 
+Controls and Procedures. 
+(a) Evaluation of Disclosure Controls and Procedures . 
+The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2019. Based on that evaluation, the Company’s management, including such officers, concluded that as of December 31, 2019 the Company’s disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by the Company in the reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to the Company’s management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure and is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. 
+(b) Management’s Report on Internal Control Over Financial Reporting. 
+The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934. Under the supervision and with the participation of the Company’s management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework, our management concluded that our internal control over financial reporting was effective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles as of December 31, 2019. 
+Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 
+The Company acquired CoreBiome, Inc., Novosanis NV, and Diversigen, Inc. collectively, the “acquired companies,” during 2019, and management excluded from its assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2019, the acquired companies’ representing approximately 11.7% of total assets and 4.0% of total revenues of the Company as of and for the year ended December 31, 2019. Management plans to fully integrate the operations of these businesses into the assessment of the effectiveness of the Company’s internal control over financial reporting in 2020. 
+62 
+The effectiveness of our internal control over financial reporting as of December 31, 201 9 has been audited by KPMG LLP, an independent registered public accounting firm, as stated in their report, which is included below. 
+(c) Changes in Internal Control Over Financial Reporting . 
+There were no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 
+(d) Report of Independent Registered Public Accounting Firm . 
+To the Stockholders and Board of Directors 
+OraSure Technologies, Inc.: 
+Opinion on Internal Control Over Financial Reporting 
+We have audited OraSure Technologies, Inc. and subsidiaries’ (the Company) internal control over financial reporting as of December 31, 2019, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission . In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2019, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. 
+We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2019 and 2018, and the related consolidated statements of income, comprehensive income, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2019, and related notes (collectively, the consolidated financial statements), and our report dated March 2, 2020 expressed an unqualified opinion on those consolidated financial statements. 
+The Company acquired CoreBiome, Inc., Novosanis NV and Diversigen, Inc. (collectively, the “Acquired Companies”) during 2019, and management excluded from its assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2019, the Acquired Companies’ internal control over financial reporting associated with 11.7% of total assets and 4.0% of total revenues included in the consolidated financial statements of the Company as of and for the year ended December 31, 2019. Our audit of internal control over financial reporting of the Company also excluded an evaluation of the internal control over financial reporting of the Acquired Companies. 
+Basis for Opinion 
+The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. 
+We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. 
+Definition and Limitations of Internal Control Over Financial Reporting 
+A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding 
+63 
+prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. 
+Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 
+/s/ KPMG LLP 
+Philadelphia, Pennsylvania 
+March 2, 2020

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+TRANSACTIONS WITH RELATED PERSONS 
+Since January 1, 2019, there have been no transactions with related persons that would require disclosure in this Proxy Statement. The Audit Committee is required to review and approve in advance all transactions with related persons involving the Company. The Audit Committee may approve a related party transaction if the transaction is on terms 
+21 
+comparable to those that could be obtained in arms’ length dealings with an unrelated third party. The Audit Committee also reviews any public disclosures of a related party transaction contained in our SEC filings. These responsibilities are described in the Audit Committee’s charter, a copy of which is available on our website at www.orasure.com . 
+Information regarding employment, severance and retirement agreements between our executive officers and the Company is set forth in the Section entitled, “Employment Agreements and Potential Payments Upon Termination or Change of Control,” in this Proxy Statement. 
+22

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+ITEM 1. 
+Business. 
+The overall goal of our Company is to empower the global community to improve health and wellness by providing access to accurate essential information. Our business is made up of two principal segments. The first is our Diagnostics business, previously named “OSUR”, which consists primarily of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using our proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Our diagnostic products include tests for diseases including HIV and Hepatitis C that are performed on a rapid basis at the point of care and tests that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. Our HIV product is also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and as a self-test to individuals in a number of other countries. Our Diagnostics business includes the operations of UrSure Inc., which we acquired and merged into OraSure in 2020. This part of the business develops and commercializes products that determine adherence to HIV medications including pre-exposure prophylaxis or PrEP, the daily medication to prevent HIV infection. These products include laboratory-based tests that can measure levels of the medication in a patient’s urine or blood, as well as point-of-care products currently in development. 
+The second segment is our Molecular Solutions business, previously named “DNAG,” which is operated primarily through our subsidiaries, DNA Genotek Inc. (“DNAG”), a company based in Ottawa, Canada, Diversigen, Inc. (“Diversigen”) and Novosanis NV (“Novosanis”). In the Molecular Solutions business, we manufacture and sell kits that are used to collect, stabilize, transport and store biological samples of genetic material for molecular testing. Our products are used for academic research and commercial applications, including ancestry, disease risk management, lifestyle and animal testing. Included in the disease risk management area are pharmacogenomics testing, hereditary disease screening, prenatal or cancer screening, population health initiatives and other molecular testing using DNA or RNA for diagnosis of acute disease. We also sell research use only collection products into the microbiome market. We also offer our customers a suite of genomics and microbiome services that range from package customization and study design optimization to extraction, analysis and reporting services. The microbiome laboratory and bioinformatics services are provided by Diversigen, which includes the operations of CoreBiome, Inc. (“CoreBiome”), a subsidiary we acquired in early 2019. CoreBiome and Diversigen were merged together in 2020. Novosanis manufactures and sells the Colli-Pee ® collection device for the volumetric collection of first-void urine for use in research, screening and diagnostics in the liquid biopsy and sexually transmitted infection markets. Our Molecular Solutions business serves customers in many countries worldwide, including many leading research universities and hospitals. 
+Additional information about us can be found on our website, www.orasure.com . We make available free of charge through a link provided at such website our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and our other filings with the Securities and Exchange Commission (“SEC”), as well as any amendments to those Reports and filings. These Reports and filings are made available as soon as reasonably practicable after they are filed with or furnished to the SEC. Our website and the information contained in or connected to that website are not intended to be incorporated by reference into this Annual Report. 
+Diagnostics Segment Products 
+The following is a summary of our principal products for the infectious disease and risk management markets, which comprise the Diagnostics segment of our business: 
+OraQuick ® Rapid HIV Test 
+OraQuick ® is our rapid point-of-care test platform designed to test oral fluid, whole blood (i.e., both finger-stick and venous), plasma and serum samples for the presence of various antibodies or analytes. The device uses a porous flat pad to collect an oral fluid specimen. After collection, the pad is inserted into a vial containing a pre-measured amount of developer solution and allowed to develop. When blood, plasma or serum is to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer solution, after which the collection pad is inserted into the solution and allowed to develop. In all cases, the specimen and developer solution then flow through the testing device where test results are observable in approximately 20 minutes. The OraQuick ® device is a screening test and requires a confirmation test where an initial positive result is obtained. 
+3 
+This product is sold under the OraQuick ADVANCE ® name in North America, Europe and certain other countries and under the OraQuick ® name in other developing countries. The test has received pre-market approval (“ PMA ”) from the U.S. Food and Drug Administration (“ FDA ”) for the detection of antibodies to both HIV-1 and HIV-2 in oral fluid, finger-stick whole blood, venous whole blood and plasma. This test is available for use by laboratories located in the United States certified under the Clinical Laboratory Improvements Amendment of 1988 (“ CLIA ”) , to perform moderately complex tests. We have also received a CLIA waiver for use of the test with oral fluid and finger-stick and venous whole blood. As a result, the test can be used by numerous additional sites in the United States not certified under CLIA to perform moderately complex tests, such as outreach clinics, community-based organizations and physicians’ offices. 
+On the international front, we have obtained a CE mark for our OraQuick ADVANCE ® test so that we can sell this product in Europe and other countries accepting the CE mark for commercialization and this product is registered for sale in other countries. We have distributors in place for several countries and are seeking to increase awareness and expand our distribution network for this product throughout the world. We have also received World Health Organization (“WHO”) pre-qualification for our export-only version of this product. 
+OraQuick ® In-Home HIV Test 
+The OraQuick ® In-Home HIV test is an OTC oral-fluid only version of our OraQuick ADVANCE ® HIV 1/2 Antibody Test. We received PMA approval to sell this test in the U.S. OTC market. We have also received a CE mark for the OraQuick ® In-Home HIV test, although this product is not currently sold in the European Union. The In-Home test is performed in the same manner as the OraQuick ADVANCE ® test, except that it has product labeling and instructions designed for consumers. In addition, we have established toll-free, 24/7, 365-day per year customer telephone support to provide additional information and referral services for consumers that use this product. 
+OraQuick ® HIV Self-Test 
+The OraQuick ® HIV Self-Test is sold for use by individuals in certain foreign countries at a lower cost to meet the needs of those markets. This product has received WHO pre-qualification and is eligible for procurement by purchasing entities entitled to access funding and other resources from the Global Fund, UNITAID and other agencies. 
+OraQuick ® HCV Rapid Antibody Test 
+Another test available on the OraQuick ® platform is the OraQuick ® HCV rapid antibody test. This product is a qualitative test that can detect antibodies to the hepatitis C virus (“HCV”), in a variety of sample types. The OraQuick ® HCV test operates in substantially the same manner as the OraQuick ADVANCE ® HIV test. 
+We have received FDA approval and CLIA waiver for use of the test in detecting HCV antibodies in venous whole blood and finger-stick whole blood specimens, making it the first and only rapid HCV test approved by the FDA for use in the United States. The OraQuick ® HCV test has received a CE mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum and is sold in Europe. This CE-marked product is also registered and sold in other foreign countries and has received WHO pre-qualification. 
+OraQuick ® Ebola Rapid Antigen Test 
+We have received 510(k) clearance from the FDA for our rapid Ebola test, making it the first and only rapid Ebola test cleared for sale in the U.S. This product utilizes the OraQuick ® technology platform for the detection of Ebola antigen and can be used with finger-stick and whole blood samples from live patients and oral fluid samples from recently deceased individuals. The uses for this test are limited to individuals that meet certain criteria indicating they may be infected with the Ebola virus, so the test is not available for general screening of individuals that do not meet this criteria. 
+4 
+OraSure ® Collection Device 
+Our OraSure ® oral fluid collection device is used in conjunction with screening and confirmatory tests for HIV-1 antibodies. The generic version of this product can be used for other analytes. This device consists of a small, treated cotton-fiber pad on a handle that is placed in a person’s mouth for two to five minutes. The device collects oral mucosal transudate (“OMT”), a serum-derived fluid that contains higher concentrations of certain antibodies and analytes than saliva. As a result, OMT testing is a highly accurate method for detecting HIV-1 infection and other analytes. 
+The OraSure ® collection device is FDA approved for use in the detection of HIV-1 antibodies. The generic version is a Class I medical device for the detection of cocaine and cotinine in oral fluid specimens for risk assessment testing. HIV-1 antibody detection using the OraSure ® collection device involves three steps: 
+• 
+Collection of an oral fluid specimen using the OraSure ® device; 
+• 
+Screening of the specimen for HIV-1 antibodies at a laboratory with an enzyme immunoassay (“EIA”) screening test approved by the FDA for use with the OraSure ® device; and 
+• 
+Laboratory confirmation of any positive screening test results with a blood-based nucleic acid test. 
+A trained health care professional then conveys test results and provides appropriate counseling to the individual who was tested. 
+Intercept ® Drug Testing System 
+A collection device that is substantially similar to the OraSure ® collection device is sold under the name Intercept ® , and is used to collect oral mucosal transudate or OMT for oral fluid drug testing. We have received FDA 510(k) clearance to use the Intercept ® collection device with laboratory-based EIAs to test for drugs-of-abuse commonly identified by the National Institute for Drug Abuse (“NIDA”) as the NIDA-5 (i.e., tetrahydrocannabinol (“THC” or marijuana), cocaine, opiates, amphetamines/methamphetamines and phencyclidine (“PCP”)), and for barbiturates, methadone and benzodiazepines. Each of these EIAs is also FDA 510(k) cleared for use with the Intercept ® device. Our Intercept ® device and oral fluid assays are sold in the U.S. primarily through laboratory distributors. 
+We believe that the Intercept ® device has several advantages over competing urine and other drugs-of-abuse testing products, including its lower total testing cost, its non-invasive nature, mobility and accuracy, the ease of maintaining a chain-of-custody, the treatment of test subjects with greater dignity, no requirement for specially-prepared collection facilities and difficulty of sample adulteration. The availability of an oral fluid test is intended to allow our customers to test for drug impairment and eliminate scheduling costs and inconvenience, thereby streamlining the testing process. 
+We have also developed a next-generation collection device, which we are marketing under the tradename “Intercept i2 ® he ”. This device offers several important advantages over our original Intercept ® device, including a sample adequacy indicator that provides a visual prompt when the appropriate volume of oral fluid has been collected, the ability to collect a larger sample required by current laboratory testing protocols and a more optimized chemistry that results in improved recovery of the targeted drug analytes. The Intercept i2 ® he device is currently being sold as a forensic use only device within the criminal justice and drug treatment markets along with a NIDA-5 panel of fully-automated high-throughput oral fluid drug assays that we distribute under an agreement with Thermo Fisher Scientific (“Thermo Fisher”). Under the Thermo Fisher agreement, we intend to obtain FDA 510(k) clearance of our device for use with a 12-assay panel of the Thermo Fisher assays that will meet the oral fluid drug testing guidelines issued by the Substance Abuse and Mental Health Services Administration (“SAMHSA”). 
+Immunoassay Tests and Reagents 
+We develop and sell immunoassay tests in formats, known as MICRO-PLATE and AUTO-LYTE ® , to meet the specific needs of our customers. We also sell fully-automated high-throughput oral fluid drug assays developed under our agreement with Thermo Fisher. Our MICRO-PLATE tests can be performed on commonly used instruments and can detect drugs in urine, serum and sweat specimens. MICRO-PLATE tests are also used as part of the Intercept ® product line to detect drugs-of-abuse in oral fluid specimens and we are selling a NIDA-5 panel of microplate assays supplied by Thermo Fisher to the U.S. forensic market under the agreement described above. AUTO-LYTE ® tests are sold in the form of bottles of liquid reagents, are run on commercially available laboratory-based automated analytical instruments, and are typically used in high volume, automated, commercial reference insurance laboratories to detect certain drugs or chemicals in urine. 
+5 
+Q.E.D. ® Saliva Alcohol Test 
+Our Q.E.D. ® saliva alcohol test is a point-of-care test device that is a cost-effective alternative to breath or blood alcohol testing. The test is a quantitative, saliva-based method for the detection of ethanol, has been cleared for sale by the FDA and has received a CLIA waiver. The U.S. Department of Transportation (“DOT”) has also approved the test. 
+Each Q.E.D. ® test kit contains a collection stick that is used to collect a sample of saliva and a disposable detection device that displays results in a format similar to a thermometer. The Q.E.D. ® device is easy to operate and instrumentation is not required to read the result. The product has a testing range of 0 to 0.145% blood alcohol and produces results in approximately two minutes. 
+Molecular Solutions Segment 
+Genomic Products 
+We sell a number of genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA and/or RNA from human and animal biologic samples. Our lead products are sold under the Oragene ® and ORAcollect ® brands and are used to collect genetic material from human saliva. These products are currently sold to thousands of academic research and commercial customers in many countries worldwide. 
+Our genomic products are available in several different configurations and contain proprietary chemical solutions that are optimized for the specific application for which each product is designed. Product physical design is focused on ease-of-use and reliability for self or assisted collection of samples. For example, several of the Oragene ® products require users to simply hold the product close to their mouth and spit into the collection device. When the container is closed, the reagents stored in the lid of the container are mixed with the captured saliva and immediately protect the nucleic acids in the sample. This non-invasive collection method yields nucleic acid that remains stable at ambient temperature for extended periods. The stabilizing technology results in high quality and high quantity nucleic acids that are required for most genetic testing and analysis methods. 
+We believe these products provide significant advantages over competing DNA and RNA collection methods such as blood collection or buccal swabs, particularly in human genetic applications. Benefits include the reliable collection of high-quality and stable genetic samples, use of simple non-invasive collection methods, the ability to store and transport collected samples for extended periods at ambient temperatures and compatibility with fully-automated laboratory testing systems. 
+We also sell the Colli-Pee ® collection device for the volumetric collection of first void urine samples. This product is used in liquid biopsy applications for the prostate and bladder cancer markets and in the sexually transmitted infection screening market. 
+COVID Products 
+During 2020, we actively engaged with several laboratories and researchers to demonstrate the effectiveness of our existing collection products for use with COVID-19 molecular testing. The stabilization solution in our molecular collection products can accommodate a very broad spectrum of microbiome activity spanning bacteria to viruses and we have collected data on the usability of our kits for this purpose. We believe that oral samples collected using devices from our product lines for liquid saliva or oral swab samples are a suitable alternative to more commonly used samples collected with a nasopharyngeal or oropharyngeal swab. Unlike nasopharyngeal and oropharyngeal swabs which cannot be self-administered easily, our products are optimized for self-collection. That means healthcare providers, retailers, and online vendors could ship our kits directly to an individual’s home, eliminating unnecessary trips to hospitals, doctors’ offices and testing facilities. Self-collection would also support the social distancing guidelines already in place in many communities, reduce the burden on testing sites and healthcare facilities, and provide wider access to testing. Moreover, the chemistry in our products stabilizes nucleic acids, including RNA, which is the nucleic acid used by most labs for COVID-19 testing. The usability and form factor of these products are conducive to use in at-home or clinic settings. 
+As a result, during 2020 we began selling our ORAcollect ® • RNA and OMNIgene ® • ORAL collection devices for use in connection with COVID-19 molecular testing. These products have become an increasingly important part of our business and accounted for 47% of 2020 revenue generated by our Molecular Solutions segment. 
+6 
+Microbiome Products . 
+We also market several microbiome collection products designed to collect, stabilize and transport the microbial profile from multiple sample types. Unlike genomic DNA, the microbiome of a sample can change over time, especially when exposed to temperature and environment fluctuations. In order to optimize and standardize sample results, a reliable method that captures and preserves (“snapshots”) the microbiome after collection until analysis is required. We believe our products provide such a reliable method. 
+Our OMNIgene ® • GUT product is an all-in-one system designed to enable an individual to easily self-collect high quality microbial DNA from feces or stool samples for gut microbiome profiling for use in clinical laboratory and research settings. Current methodologies for gut microbiome profiling have distinct shortcomings due to the introduction of bias, leading to a lack of reproducibility in the field. Our product ensures that the fecal sample is fully stabilized immediately upon collection and maintains an accurate and reliable bacterial profile for weeks at room temperature. We have also begun marketing other microbiome collection kits for skin, vaginal and oral samples. 
+Laboratory and Data Analytical Services . 
+Our Molecular Solutions business also offers our customers microbiome laboratory testing and analytical services. These services reflect the collective services of our CoreBiome and Diversigen subsidiaries, which were combined under the Diversigen name during 2020. Our services focus on accelerating microbiome discovery for customers in the pharmaceutical, agriculture, and research communities, to unleash the translational potential of the microbiome and provide fast and information-rich characterizations of microbial diversity and function paired with expert analytics. We also provide comprehensive microbiome and metagenomics services focused on solutions to improve human, animal and environmental health. Diversigen has extensive experience with highly diverse microbiome sample types and provides full project life cycle consulting services, including pre-project consulting, study design, extraction and sequencing to complete bioinformatics analysis. Diversigen is at the forefront for setting quality standards for this industry and is in the process of obtaining College of American Pathologists (“CAP”) accreditation at its laboratory facilities. We are also in the process of integrating the services offered through GenoFIND TM , CoreBiome and Diversigen into a unified offering and brand for our customers. 
+Regulatory Approvals. 
+Our Molecular Solutions products historically have been sold primarily as Class I medical devices for use by research and academic institutions. We have received FDA 510(k) clearance of the Oragene ® • DX product for use with the eSensor ® Warfarin sensitivity saliva test. A separate 510(k) clearance permits self-collection by consumers when the sample is to be tested with either an exempt or 510(k) cleared molecular test. More recently, we received a generic 510(k) clearance for this product, which we believe will further broaden the use of our Oragene ® • DX device. Our ORAcollect ® product similarly received 510(k) clearance from the FDA. We have also received CE mark approval for the Oragene ® • DNA, ORAcollect ® and OMNIgene ® • GUT collection kits. Diversigen provides molecular services in CLIA-certified laboratories and as noted above, and is in the process of obtaining CAP accreditation. 
+With respect to COVID testing, our collection devices have been included in FDA Emergency Use Authorizations (“EUAs”) granted to a number of third parties for use with COVID-19 molecular test offerings. These EUAs permit the use of our devices in healthcare settings or in some cases in at-home or unsupervised settings for the collection of samples. Our DNA Genotek subsidiary also received FDA EUAs for the use of its OMNIgene ® •ORAL and ORAcollect ® •RNA collection devices in COVID-19 testing which allows for the unsupervised use of these devices at home or in healthcare settings when used as part of an approved or validated at-home test kit. With these FDA authorizations, the OMNIgene ® • ORAL and ORAcollect ® •RNA devices can be used for the self-collection, transport and laboratory testing of saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA), without the presence of a healthcare professional, before sending the sample to a lab for analysis. These products are also CE marked for in vitro diagnostic use, including for COVID-19 testing, in the European Union. 
+Products Under Development 
+Diagnostic Products 
+Our research and development efforts include programs targeted at expanding and enhancing our diagnostics business. These programs typically focus on products related to drug monitoring, rapid tests for diseases other than HIV and HCV and drug testing. In 2020, significant time and resources were dedicated to the development of our COVID-19 Rapid Antigen Self-Test. Subject to regulatory approvals, the Company intends to introduce its antigen test to the market for three different uses: 
+7 
+▪ 
+Professional Test for use at drive-through sites, physician offices, public health testing sites, and employer/university health centers. In this instance, a physician would prescribe the test and the patient would conduct a self-swab in the presence of a healthcare provider who would then interpret the result. 
+▪ 
+Prescription Self-Test for use by individual consumers (with prescription) at home or in any location, by employers/universities on- or off-site, or by physicians or public health via remote testing. In this instance, a physician would prescribe the test and the patient would conduct a self-swab at home, or in any location, where they would then interpret their own result. 
+▪ 
+OTC Self-Test for use by consumers who would purchase online or at retail without prescription, and conduct the test and receive the result themselves anytime, anywhere. 
+We have completed development of the COVID-19 Rapid Antigen Self-Test and have collected all clinical study data to submit both the Prescription Self-Test and the Professional Test versions of this product for EUA at the same time, which is expected to occur in the first quarter of 2021. Subject to receipt of EUA, this product would test for active COVID-19 infection using nasal samples self-collected from the lower nostril. After we submit the Professional Test and Prescription Self-Test for EUA, we intend to continue plans to pursue an OTC claim. 
+During the third quarter of 2020, limit of detection studies for the assay were completed with live coronavirus in a certified third party analytical laboratory, with results comparable to that of another EUA approved, instrument-free, rapid antigen test. The results from the limit of detection comparison provides further confidence that the proprietary chemistries incorporated on OraSure’s lateral flow test strip will deliver the analytical sensitivity needed. Although the timing of EUA approval is subject to FDA review, the Company will be prepared to launch the test, subject to authorization, without delay following such approval. Subject to receipt of EUA, this product would test for active COVID-19 infection using nasal samples collected from the lower nostril. Results would be available at the point of collection, with no special instrumentation needed to interpret result. 
+In addition to a rapid antigen self-test, we are developing a lab-based oral fluid microplate SARS-CoV-2 antibody enzyme-linked immunosorbent assay (“ELISA”). The OraSure SARS-CoV-2 Antibody ELISA is intended for qualitative detection of total antibodies (including IgM/IgA/IgG) to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device. To date, there are no oral fluid antibody tests for COVID-19 authorized for sale in the U.S. Oral sample collection is quick, painless, non-invasive and requires less human contact in comparison to a blood draw, minimizing the need for personal protective equipment and exposure to potentially infected patients. With this test, individuals would use a collection pad to self-collect an oral fluid sample under the observation of a healthcare professional. The sample would then be placed into the OraSure oral antibody collection device buffer for storage and transport, and then later dispensed onto the ELISA microplate for testing in a laboratory. The lab-based antibody test can aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Antibody tests are well suited for community surveillance and seroprevalence studies to identify people in a population or community that have antibodies against an infectious disease such as COVID-19. In addition, the OraSure SARS-COV-2 Antibody ELISA can detect antibodies developed from vaccination. 
+In October 2020, the Company submitted an EUA application to the FDA for its SARS-CoV-2 Antibody ELISA test and in December 2020, the FDA requested additional information as part of its review of our EUA submission. At the FDA’s request, we are performing additional analytical studies on sample collection and stability and, after data from these studies have been obtained, we intend to resubmit two separate EUAs – one for the ELISA and one for the collection device. 
+During 2020, a significant amount of time was also devoted to the oral fluid drug assay development efforts with Thermo Fisher. Another development area focused on increasing the number of country registrations for our HIV Self-Test. Finally, we are also working to develop a rapid point-of-care assay to determine HIV drug adherence to be sold in the same markets where we currently sell our HIV diagnostic products. 
+Molecular Solutions 
+In order to intersect evolving customer needs within the academic and commercial markets, our molecular business product development pipeline is focused on extending offerings across different sample types and analytes within both the genomics and microbiome areas. Genomic customers are demonstrating an increasing demand for RNA collection and stabilization. On the microbiome front, we continue to focus research and development work on collecting and stabilizing microbial DNA, RNA and metabolites from multiple sample types including gut, skin, vagina and saliva. We are also evolving the physical design and features of our products to further enable high throughput processing through improved interoperability with automated platforms. 
+The field of microbiome services is fast paced with evolving biological understanding and development of new methodologies. Our development efforts are focused on remaining at the forefront of technology, as well as providing new and relevant services to our customers. These development goals are being pursued while we also leverage new sequencing technologies and methodologies to enable scalability for our business. 
+8 
+Sales and Marketing 
+We attempt to reach our major target markets through a combination of direct sales, strategic arrangements and independent distributors. Our marketing strategy is to create or raise awareness through a full array of marketing activities, which include trade shows, print advertising, special programs, distributor promotions, telemarketing and the use of digital and social media in order to stimulate sales in each target market. 
+We market our products in the United States and internationally. Consolidated net revenues attributable to customers in the United States were $130.8 million, $107.3 million and $136.8 million in 2020, 2019 and 2018, respectively. Consolidated net revenues attributable to international customers amounted to $40.9 million, $47.3 million and $44.9 million, or 24%, 31% and 25% of our total revenues, in 2020, 2019 and 2018 respectively. For more information about our revenues and long-lived assets attributable to U.S. and international customers, please see Notes 2 and 13 to our consolidated financial statements included elsewhere in this Annual Report. 
+Diagnostics - Professional 
+We market the OraQuick ADVANCE ® HIV-1/2 antibody test directly to customers in the public health market for HIV testing. This market consists of a broad range of clinics and laboratories and includes states, counties, and other governmental agencies, family planning clinics, colleges and universities, correctional facilities and the military. There are also a number of organizations in the public health market, such as AIDS service organizations and various community-based organizations, that are set up primarily for the purpose of encouraging and enabling HIV testing. We sell our OraQuick ADVANCE ® test directly to hospitals in the U.S. primarily through distributors. We also use distributors to sell our OraQuick ADVANCE ® test into the U.S. physician office market and to retail clinics operated by pharmacies. In addition, we distribute our OraQuick ® HIV test in certain foreign countries through distributors. 
+Our OraQuick ® HCV test is sold primarily to the same markets where our OraQuick ® ADVANCE HIV test is sold, including public health organizations, hospitals, physicians and retail clinics. We also sell this test in other countries through distributors. 
+Diagnostics - OTC and Self-Test 
+We sell our OraQuick ® In-Home test in the U.S. retail or consumer market. Retailers carrying the product include CVS, Walgreens, Rite Aid and Walmart. The product is also available for purchase on-line through certain retailers and from our website, www.oraquick.com . The primary target population for our HIV-OTC test comprises young, sexually active adults, with greater purchase intent found in high-risk sub-groups, such as men who have sex with men, African Americans and Latino Americans. 
+We also sell our OraQuick ® HIV Self-Test in certain international markets. Under a Charitable Support Agreement with the Bill & Melinda Gates Foundation (“Gates Foundation”) we are able to offer our OraQuick ® HIV Self-Test at an affordable price in 50 developing countries in Africa and Asia with funding from the Gates Foundation. The funding consists of support payments tied to the volume of product we sell and reimbursement of certain related costs. The agreement was entered into in 2017 and has a four-year term and enables non-governmental organizations in the eligible countries that receive funding from government or public sector agencies and donors to access our HIV Self-Test at reduced pricing. The agreement with the Gates Foundation provides for an aggregate funding amount not to exceed $20.0 million over the four-year term or $6.0 million each year of the agreement. The term of this agreement expires in 2021. 
+Our OraQuick ® HIV Self-Test is the only oral fluid HIV test prequalified by the WHO. WHO prequalification helps ensure that diagnostic tests for high burden diseases meet global standards of quality, safety, and efficacy in order to optimize use of health resources and improve health outcomes. WHO prequalification enables governmental organizations implementing HIV Self-Test pilots and programs to access international funding to purchase our test. 
+Substance Abuse Testing 
+Our substance abuse testing products are marketed to laboratories serving the workplace testing, forensic toxicology, criminal justice and drug rehabilitation markets in the U.S. and certain international markets. 
+We have entered into agreements for the distribution of our Intercept ® collection device and associated MICRO-PLATE assays for drugs-of-abuse testing in the workplace testing market in the United States and Canada through several laboratory distributors and internationally for workplace, criminal justice and forensic toxicology testing through other distributors. We also market the Intercept ® collection device on its own and as a kit in combination with laboratory testing services. To better serve our workplace customers, we have contracted with commercial laboratories to provide prepackaged Intercept ® test kits, with prepaid laboratory testing and specimen shipping costs included. 
+9 
+The criminal justice market in the United States for our substance abuse testing products consists of a wide variety of entities in the criminal justice system that require drug screening, such as pre-trial services, parole and probation offices, police forces, drug courts, prisons, drug treatment programs and community/family service programs. The forensic toxicology market consists of several hundred laboratories including federal, state and county crime laboratories, medical examiner laboratories and reference laboratories. 
+As discussed above, we also sell our next generation Intercept i2 ® collection device with a NIDA-5 panel of fully-automated high-throughput oral fluid assays developed with Thermo Fisher for the detection of PCP, THC, opiates, cocaine, methamphetamines and amphetamines. These products are currently sold into the criminal justice and drug treatment markets. Under our Thermo Fisher agreement, we intend to obtain FDA 510(k) clearance of our Intercept i2 ® device for use with the NIDA-5 assay panel, along with an additional six fully-automated high-throughput assays in order to expand sales of this product line into the workplace testing market and other markets that require 510(k) cleared drug tests. These products are expected to meet recent oral fluid drug testing guidelines issued by SAMHSA, which will enable us to expand sales into markets where employee drug testing is federally regulated. 
+We distribute our Q.E.D. ® saliva alcohol test primarily through various distributors in the United States and internationally. The markets for alcohol testing are relatively small and fragmented with a broad range of legal and procedural barriers to entry. Markets range from law enforcement testing to workplace testing of employees in safety sensitive occupations. Typical usage situations include pre-employment, random, post-accident, reasonable-cause and return-to-duty testing. 
+Molecular Solutions 
+Our Molecular Solutions business sells its products directly to its customers, primarily through its own internal sales force and in many international markets, distributors are used. 
+Most of our Molecular Solutions revenues are derived from product sales to commercial customers and sales into the academic and research markets. Sales to commercial customers providing consumer genetics and clinical diagnostic services have been increasing and account for a majority these revenues. A significant portion of total sales are derived from repeat customers in both markets. Molecular Solutions also has customers in the livestock and companion animal markets. 
+We have expanded the market focus of our Molecular Solutions business by selling certain existing collection products for use in COVID-19 tests and by developing new collection devices for the emerging microbiome market, which is focused on the study of microbes and their effect on human health. Our primary product offering in the microbiome market, OMNIgene ® • GUT, is focused on the human gut microbiome (microbes living in human stool). We are leveraging our existing sales force and global research connections to engage microbiome customers around the world to establish itself as the leader in ease-of-collection, stabilization and transport of this challenging sample type. 
+Our Molecular Solutions segment includes the Colli-Pee ® device, a product developed and sold by our Novosanis subsidiary, for the volumetric collection of first void urine. This product is in its early stages and initial sales are occurring primarily through distributors and collaborations for use in the liquid biopsy and sexually transmitted disease markets. 
+This segment is offering laboratory and analytical services for both genomics and microbiome customers in order to more fully meet the needs of its customers. These services are primarily provided to pharmaceutical and biotech companies and research institutions. During 2019, we substantially expanded our ability to offer microbiome laboratory and bioinformatics services with the acquisition of CoreBiome and Diversigen. The laboratory operations of CoreBiome and Diversigen were combined during 2020 so that we can now provide a single-integrated offering to our customers under the Diversigen brand. 
+Significant Products and Customers 
+Several different product lines have contributed significantly to our financial performance, accounting for 10% or more of our total revenues during the past three years. The table below shows a breakdown of those product lines (dollars in thousands). 
+For the years ended December 31, 
+2020 
+2019 
+2018 
+Genomics 
+$ 
+37,141 
+$ 
+56,200 
+$ 
+79,765 
+OraQuick ® HIV 
+44,224 
+43,092 
+41,457 
+COVID-19 
+49,802 
+— 
+— 
+One of our customers accounted for approximately 15% and 24% of our net consolidated revenues in 2019 and 2018, respectively. We had no customers in 2020 that accounted for more than 10% of our net consolidated revenues. 
+10 
+Supply and Manufacturing 
+We manufacture all of our OraQuick ADVANCE ® HIV test, OraQuick ® In-Home HIV test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® collection devices, AUTOLYTE and MICRO-PLATE assays and QED ® saliva alcohol test in our Bethlehem, Pennsylvania facilities. We expect to continue to manufacture these products at this location for the foreseeable future. 
+We have contracted with a third party in Thailand for the assembly of the OraQuick ® HIV device and the OraQuick ® HIV Self-Test in order to supply certain international markets. We believe that other firms would be able to assemble these OraQuick ® tests on terms no less favorable than those set forth in the agreement if the Thailand contractor would be unable or unwilling to continue assembling this product. 
+We can purchase the HIV antigens, the nitrocellulose and certain other critical components, and the HCV and Ebola antigens used in our OraQuick ® product lines only from a limited number of sources. If for any reason these suppliers are unwilling or no longer able to supply our antigen or nitrocellulose needs, we believe that alternative supplies could be obtained at a competitive cost. However, a change in any of the antigens, the nitrocellulose or other critical components used in our products would require FDA approval and some additional development work. This in turn could require significant time to complete, increase our costs and disrupt our ability to manufacture and sell the affected products. 
+We intend to manufacture our COVID-19 Rapid Antigen Self-Test and OraSure SARS-CoV-2 Antibody ELISA in our Bethlehem, Pennsylvania facilities. In addition, we plan to manufacture our COVID-19 Rapid Antigen Self-Test at a third party in Thailand in order to supply certain international markets. We made significant capital investments during 2020 and will continue to invest to add the manufacturing capacity needed to meet the expected demand for these products. Specifically, we plan to add capacity of 70 million tests per year (which includes tests for HIV, HCV and Ebola) to meet demand for the COVID-19 Rapid Antigen Self-Test in the U.S. by the third quarter of 2021, and capacity for an additional 50 million tests per year by the second quarter of 2022 to support sales of this product outside of the U.S. We expect to add capacity of 20 million tests per year (including existing products) to meet demand for our OraSure SARS-CoV-2 Antibody ELISA by the fourth quarter of 2021. 
+Our MICROPLATE and AUTO-LYTE assays require the production of highly specific and sensitive antibodies corresponding to the antigen of interest. Substantially all our antibody requirements are provided by contract suppliers. We believe that we have adequate reserves of antibody supplies and that we have access to sufficient raw materials for these products. 
+The fully-automated high-throughput oral fluid drug assays sold with our new Intercept i2 ® collection device are manufactured and supplied under a long-term agreement with Thermo Fisher. There is no other supply source for these products. 
+DNAG has three long-term contract manufacturing relationships to supply virtually all of its products, including the Oragene ® product line. Many of the raw materials and components used in these products are also purchased from third parties, including one critical component that is purchased from a sole source supplier. We believe there are other suppliers that can manufacture and supply the raw materials and components for the DNAG products. We are increasing capacity for our molecular collection kits to meet demand for COVID molecular testing to 80 million kits per year (including non-COVID kits) by the third quarter of 2021. 
+Our Colli-Pee ® device is currently manufactured at our Belgian assembly facility with components supplied by third party vendors. 
+Our GenoFIND TM genomics laboratory services are provided to our customers by a third party laboratory. We believe there are other laboratories that can also provide these services. Our microbiome laboratory testing and analytical services are provided by our subsidiary, Diversigen. 
+11 
+Human Capital Resources 
+In order to achieve the goals and expectations of our Company, it is crucial that we continue to attract and retain top talent. To facilitate talent attraction and retention, we strive to make OraSure a safe and rewarding workplace with opportunities for our employees to grow and develop in their careers. 
+As of December 31, 2020, we had 570 full-time employees, which compares to 472 employees as of December 31, 2019. The increase in employees during 2020 was primarily the result of the need to add manufacturing capacity for our COVID-19 Rapid Antigen Self-Test and molecular collection devices used in COVID-19 molecular testing. Our employees are not currently represented by a U.S. collective bargaining agreement. 
+We believe our employees are among our most important resources and are critical to our continued success. We focus significant attention to attracting and retaining talented and experienced individuals to manage and support our operations, and our management team routinely reviews employee turnover rates at various levels of the organization. Management also reviews employee engagement and satisfaction surveys to monitor employee morale and receive feedback on a variety of issues. 
+The health and safety of our workforce is fundamental to the success of our business. We safeguard our people, projects and reputation by striving for zero employee injuries and illnesses, while operating and delivering our work responsibly and sustainably. We provide our employees upfront and ongoing safety training to ensure that safety policies and procedures are effectively communicated and implemented. Personal protective equipment is provided to those employees where needed for the employee to safely perform their job function. 
+During 2020, in response to the COVID-19 pandemic, we implemented safety protocols and new procedures to protect our employees, our subcontractors and our customers. These protocols include complying with social distancing and other health and safety standards as required by federal, state and local government agencies, taking into consideration guidelines of the Centers for Disease Control and Prevention and other public health authorities. In addition, we modified the way we conduct many aspects of our business to reduce the number of in-person interactions. For example, we significantly expanded the use of virtual interactions in all aspects of our business, including customer facing activities. Many of our administrative and operational functions during this time have required modification as well, including much of our workforce working remotely. 
+As part of our compensation philosophy, we believe that we must offer and maintain market competitive compensation and benefits programs for our employees in order to attract and retain superior talent. In addition to healthy base wages, additional programs include annual bonus opportunities, a Company matched 401(k) Plan or other savings plan, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, flexible work schedules, and employee assistance programs. 
+The OraSure family of companies is committed to creating and fostering a diverse, equitable, and inclusive workplace that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. Our management teams and all of our employees are expected to exhibit and promote honest, ethical and respectful conduct in the workplace. All of our employees must adhere to a Code of Conduct that sets standards for appropriate behavior and includes required annual training on preventing, identifying, reporting and stopping any type of unlawful discrimination. We strive to recruit the best people for the job regardless of gender, ethnicity or other protected trait and it is our policy to fully comply with all laws (domestic and foreign) applicable to discrimination in the workplace. We have an active Diversity, Equity and Inclusion Council that strives to drive diversity, equity and inclusion within the workplace. At OraSure, we believe a variety of perspectives are critical to achieving success, and that diversity, equity and inclusion are key drivers to growth-based innovation and profitability. We aim to create a culture where all people feel valued, supported, and inspired to be themselves fearlessly, without judgement. We believe that when all voices are heard, we honor and exemplify our core values and best serve our communities. 
+Competition 
+Diagnostics Segment 
+The diagnostic industry is a multi-billion dollar international industry and is intensely competitive. Many of our competitors are substantially larger than we are, and have greater financial, research, manufacturing and marketing resources than we do. 
+The primary competitive factors for our products include price, quality, performance, ease of use, customer service and reputation. Industry competition is based on these and the following additional factors: 
+• 
+Scientific and technological capability; 
+• 
+Proprietary know-how; 
+• 
+The ability to develop and market products and processes; 
+12 
+• 
+The ability to obtain FDA or other regulatory approvals; 
+• 
+The ability to manufacture products that meet applicable FDA or other applicable regulatory requirements; 
+• 
+Commercial execution and strength of distribution; 
+• 
+Access to adequate capital; 
+• 
+The ability to attract and retain qualified personnel; and 
+• 
+The availability of patent protection. 
+A few large corporations produce a wide variety of diagnostic tests and other medical devices and equipment. A larger number of mid-size companies generally compete only in the diagnostic industry and a significant number of small companies produce only a few diagnostic products. As a result, the diagnostic test industry is highly fragmented and segmented. 
+The future market for diagnostic products is expected to be characterized by greater cost consciousness, the development of new technologies, tighter reimbursement policies and consolidation. The purchasers of diagnostic products are expected to place increased emphasis on lowering costs, reducing inventory levels, obtaining better performing products, automation, service and volume discounts. The increased complexity of the market is expected to force many competitors to enter into joint ventures or license certain products or technologies. 
+We expect competition to intensify as technological advances are made and become more widely known, and as new products reach the market. Furthermore, new testing methodologies could be developed in the future that render our products impractical, uneconomical or obsolete. There can be no assurance that our competitors will not succeed in developing or marketing technologies and products that are more effective than those we develop or that would render our technologies and products obsolete or otherwise commercially unattractive. In addition, there can be no assurance that our competitors will not succeed in obtaining regulatory approval for these products, or introduce or commercialize them, before we can do so. These developments could have a material adverse effect on our business, financial condition and results of operations. 
+Several companies market or have announced plans to market oral specimen collection devices and tests both within and outside the United States. We expect the number of devices competing with our OraQuick ® , OraSure ® , Intercept ® and Intercept i2 ® devices to increase as the benefits of oral fluid-based testing become more widely accepted. 
+Competition in the U.S. market for infectious disease testing in medical settings is intense and is expected to increase. Our principal competition for HIV testing in the professional market comes from existing and new point-of-care rapid blood tests, automated laboratory-based blood tests, or other oral fluid-based tests. Our competitors sell both a rapid oral fluid HIV test and a rapid HIV antigen/antibody test that are both FDA approved and CLIA waived. Our OraQuick ® rapid HCV test competes against laboratory-based blood tests in the U.S., as there currently are no other rapid HCV testing products approved by the FDA. 
+Our competitors in the domestic infectious disease testing market include medical diagnostic companies and specialized biotechnology firms, as well as pharmaceutical companies with biotechnology divisions. Competing tests are often sold at a lower price than we charge for our products. This competition can result in lost sales and degradation of the price (and therefore the applicable profit margins) we can charge for our HIV and HCV tests. 
+Outside the U.S., our rapid HIV and HCV tests compete against other rapid and laboratory-based tests. Significant sales of these products in Europe have not materialized principally because of differences in European healthcare systems compared to U.S. systems. Unlike in the U.S., adoption of rapid point-of-care diagnostics is not widespread in Europe because laboratory testing is entrenched and healthcare systems are structured around centralized testing models. In addition, many competing tests in international markets are sold at very low prices. We intend to continue to build awareness and develop strategies to expand sales of our OraQuick ® HIV and HCV tests in European and other international markets. 
+Our OraQuick ® In-Home HIV oral fluid test is the only rapid HIV test approved by the FDA for sale in the U.S. OTC market. We compete against one other non-rapid HIV blood test available in the OTC market, which requires consumers to self-collect a blood sample and then send it to a laboratory for testing. We expect that other non-rapid HIV blood tests will eventually compete with our product. The OraQuick ® HIV Self-Test that we sell in certain international markets is facing competition from other blood-based rapid HIV self-tests. 
+In the United States there are currently four rapid COVID-19 self-tests on the market that are expected to compete against our COVID-19 Rapid Antigen Self-Test. There are several other Professional point of care COVID-19 antigen tests with EUA in the United States which are expected to compete with the Professional use version of our antigen test. In addition, there are a number of COVID-19 blood-based antibody tests sold in the U.S. market that are expected to compete against our OraSure SARS-CoV-2 Oral 
+13 
+Fluid Antibody ELISA. We also expect additional rapid COVID-19 antigen tests and COVID-19 antibody tests to enter the market both in the U.S. and in international markets that will compete against our COVID-19 assays. 
+In the substance abuse testing market, our Intercept ® drug testing system competes with laboratory-based drug testing products using sample matrices such as urine, hair, sweat and oral fluid. We expect competition for our products to intensify, particularly from other domestic and international companies that have developed, or may develop, competing oral fluid drug testing products. 
+There are at least two competitors that sell fully-automated high-throughput oral fluid drug testing products in unregulated settings in the United States. These competitors sell these assays for use with either their own oral fluid collector or a collector manufactured by another party. These offerings compete against our Intercept ® and Intercept i2 ® collection devices and related oral fluid assays. 
+Our MICRO-PLATE oral fluid drug assays, which are sold for use with the original Intercept ® collector and our OraSure ® collection device, also continue to come under increasing competitive pressure from “home-brew” assays developed internally by our laboratory customers. Our oral fluid MICRO-PLATE assays also compete with urine-based homogeneous assays that are run on fully-automated, random access analyzers. These tests provide strong competitive pressure because they provide the benefits of automation, including lower costs and short turn-around times. 
+Our MICRO-PLATE drugs-of-abuse reagents sold in the forensic toxicology market are targeted to forensic testing laboratories where sensitivity, automation and “system solutions” are important. We compete with both homogeneous and heterogeneous tests manufactured by many companies. 
+Q.E.D. ® competes against other semi-quantitative saliva-based alcohol tests that have received U.S. Department of Transportation approval as well as breath alcohol tests. Although there are lower priced tests on the market that use oral fluid or breath as a test medium, these tests are qualitative tests that are believed to be substantially lower in quality and provide fewer benefits than our Q.E.D. ® test. 
+Molecular Solutions Segment 
+Our Oragene ® and ORAcollect ® collection systems compete against other types of collection devices used for molecular testing, such as blood collection devices and buccal swabs, which often are sold for prices lower than the prices charged for the Oragene ® and ORAcollect ® products. Although we believe the Oragene ® and ORAcollect ® devices offer a number of advantages over these other products, the availability of lower price competitive devices can result in lost sales and degradation in pricing and profit margin. Our Oragene ® and ORAcollect ® products are also facing increasing competition from similarly designed collection systems which are beginning to enter the market. With the receipt of authorizations for use in connection with COVID-19 molecular tests, our Oragene ® and ORAcollect ® products now compete against COVID-19 testing systems and the collection methods used in those systems. 
+OMNIgene ® • GUT is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions developed by various researchers, including simply freezing the sample after collection. The microbiome market is expected to require standardization in the methods used for collection and stabilization in order to derive more accurate and repeatable results. To date, we are one of the few vendors to offer a solution that fully meets these requirements. 
+Our genomic and microbiome laboratory service offerings primarily compete against a number of commercial reference laboratories, specialty laboratories and hospital laboratories in the U.S. 
+Patents and Proprietary Information 
+We seek patents and other intellectual property rights to protect and preserve our proprietary technology and our right to capitalize on the results of our research and development activities. We also rely on trade secrets, know-how, continuing technological innovations and licensing opportunities to provide competitive advantages for our products in our markets and to accelerate new product introductions. We regularly search for third-party patents in fields related to our business to shape our own patent and product commercialization strategies as effectively as possible and to identify licensing opportunities. United States patents generally have a maximum term of 20 years from the date an application is filed. 
+We have four United States patents and numerous foreign patents for the OraSure ® and Intercept ® collection devices and technology relating to oral fluid collection, containers for oral fluids, methods to test oral fluid, formulations for the manufacture of synthetic oral fluid, and methods to control the volume of oral fluid collected and dispersed. The U.S. patents expire from May 2021 to December 2026. We have also applied for additional patents, in both the United States and certain foreign countries, on such products and technology. 
+14 
+We have one United States patent for our OraQuick ® platform expiring in 2028 , as well as corresponding related international patents. We also have patent applications pending internationally. We have two pending patents in the United States for our COVID-19 Rapid Antigen Self-Test and we expect to file additional patent applications for this product in certain international markets. 
+We hold, through our subsidiary, DNAG, twenty-two granted United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues. These patents expire from February 2022 through March 2035. 
+We hold through our subsidiary, Novosanis, one granted United States patents and numerous foreign patents covering a medical device for capturing a predetermined volume of first void urine. This patent expires in September 2033. 
+Our subsidiary, Diversigen, has licensed one United States patent and several foreign patent applications from the University of Minnesota for analytical standards to detect and/or measure sampling, processing, and/or amplification errors in a biological samples containing polynucleotide molecules. This license also covers certain software and know-how related to laboratory and bioinformatics procedures and processes. Diversigen has also licensed certain know-how and database assets from the Baylor College of Medicine related to laboratory processes for microbiome and metagenomics services. 
+We require our employees, consultants, outside collaborators and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed by or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees and certain consultants, the agreements also provide that all inventions conceived by the individual during his or her tenure with us or the performance by the consultant of services for us will be our exclusive property. 
+We own rights to trademarks and service marks that we believe are necessary to conduct our business as currently operated. In the United States, we own a number of trademarks, including the OraSure ® , Intercept ® , Intercept i2 ® , OraQuick ® , OraQuick ADVANCE ® , OraSure QuickFlu ® , Q.E.D. ® , Oragene ® , DNA Genotek TM , OMNImet TM , ORAcollect ® , OMNIgene ® , Diversigen ® , Colli-Pee ® , AUTO-LYTE ® , prepIT ® and Hemagene ® trademarks. We also own many of these marks and others in several foreign countries and we are pursuing registration of several other trademarks. 
+Although important, the issuance of a patent or existence of trademark or trade secret protection does not in itself ensure the success of our business. Competitors may be able to produce products competing with our patented products without infringing our patent rights. Issuance of a patent in one country generally does not prevent manufacture or sale of the patented product in other countries. The issuance of a patent is not conclusive as to validity or as to the enforceable scope of the patent. The validity or enforceability of a patent or trademark can be challenged by litigation after its issuance or registration. If the outcome of such litigation is adverse to the owner of the patent, the owner’s rights could be diminished or withdrawn. Trade secret protection does not prevent independent discovery and exploitation of the secret product or technique. 
+Government Regulation 
+General 
+Most of our products are regulated by the FDA, along with other federal, state and local agencies and comparable regulatory bodies in other countries. This regulated environment governs almost all aspects of development, production and marketing, including product design and testing, authorizations to market, labeling, advertising and promotion, manufacturing, distribution, post-market surveillance and reporting, and recordkeeping. We believe that our products and procedures are in material compliance with all applicable regulations, but the regulations regarding the manufacture and sale of our products may be unclear and are subject to change. We cannot predict the effect, if any, that these changes might have on our business, financial condition or results of operations. 
+Many of our FDA-regulated products require some form of review and action by the FDA before they can be marketed in the United States. After approval or clearance by the FDA, we must continue to comply with other FDA requirements applicable to marketed products and are subject to periodic inspections by the FDA and other regulatory bodies. Both before and after approval or clearance, failure to comply with the FDA’s requirements can lead to significant penalties or could disrupt our ability to manufacture and sell these products. In addition, the FDA could refuse permission to obtain certificates needed to export our products if the agency determines that we are not in compliance. 
+15 
+Domestic Regulation 
+Most of our products are regulated in the United States as in vitro diagnostic and medical devices. In the United States, devices are classified into three groups based on risk: class I (lowest risk), class II (moderate risk), and class III (highest risk). The classification of a device determines the level of regulation applicable to the device: class I devices are subject only to the general controls that are applicable to all regulated devices; class II devices are subject to both general controls and special controls, which are specific to the type of device; and class III devices are subject to general controls and any other controls that are needed to provide reasonable assurance of the safety and effectiveness of the specific device. 
+The classification of the device also influences the type of premarket submission that is required before the device can be marketed. Some low risk devices (including many class I and some class II devices) may be placed on the market without any premarket submission. Such devices often are referred to as “exempt” or “510(k)-exempt.” Most devices, however, require some form of premarket submission prior to marketing. There are several mechanisms by which such devices can be placed on the market in the United States, including 510(k)-clearance, de novo classification, premarket approval, or emergency use authorization. 
+Many class II devices and some class I devices may qualify for clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act. To obtain this clearance from the FDA, the manufacturer must submit to the FDA a premarket notification that it intends to begin marketing the product, and show that the product is substantially equivalent to another legally marketed predicate device (i.e., a device that has been cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976; a device that has been downclassified by the FDA; or a device that the FDA previously has determined to be exempt from the 510(k) process). To be substantially equivalent, an applicant must show that when compared to a predicate, the new device has the same intended use and same technology, or if different technology, that the new device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness. In all cases, data from some form of performance testing is required and in some cases, the submission must include data from human clinical studies. An applicant must submit a 510(k) notification at least 90 days before commercial distribution of the product commences. Marketing may only commence when the FDA issues a clearance letter finding that the new device is substantially equivalent to the predicate device. The standards and data requirements necessary for the clearance of a new device may be unclear or may be subject to change. Although FDA clearance usually takes from four to twelve months, in some cases more than a year may be required before clearance is obtained, if at all. 
+If the device does not qualify for the 510(k) procedure, either because there is no existing predicate device, it is not substantially equivalent to a legally marketed predicate device or because it is classified by the FDA as a class III device, the FDA must approve either a request for de novo classification or a premarket approval application (“PMA”) before marketing can begin. A de novo classification is an alternate pathway to classify novel devices of low to moderate risk for which no substantially equivalent predicate device exists into class I or class II. The FDA’s goal is to decide a de novo request in 150 days from the time the request is received, although it can take longer. 
+PMAs generally are required for class III devices, i.e., high risk devices, and must demonstrate, among other matters, that the medical device provides a reasonable assurance of safety and effectiveness for the intended use(s) of the device. A PMA is typically a complex submission, supported by valid scientific evidence, including the results of preclinical and clinical studies, usability data, detailed information about the manufacturing process for the device, and other data and information. Preparing a PMA is a resource-intensive and time-consuming process. Once a PMA has been submitted, the FDA is required to review the submission within 180 days. However, the FDA’s review may be, and often is, much longer, in many cases requiring one to three years or more, and may include requests for additional data, review by an independent panel of experts, and facility inspections before approval is granted, if at all. 
+If the FDA approves the PMA, it may place restrictions on the device. If the FDA’s evaluation of the PMA or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter. The FDA may also require additional clinical trials, which can delay the PMA approval process by several years or prevent a PMA approval from being obtained. 
+If the FDA discovers that an applicant has submitted false or misleading information in any application or notification, the FDA may take action against the applicant and its employees or refuse to review submissions until certain requirements are met pursuant to its Application Integrity Policy. Delays in receipt of or failure to receive such clearances or approvals, the loss of previously received clearances or approvals, or the failure to comply with existing or future regulatory requirements could have a material adverse effect on our business, financial condition and results of operations. 
+Another option for marketing a product in the U.S. is through an EUA. FDA may grant an EUA application for a product if the Secretary of Health and Human Services declares that circumstances exist justifying the authorization of emergency use of certain products. Such declaration may be made following a determination by the Secretary of Health and Human Services that there is a public health emergency, by the Secretary of Homeland Security that there is a domestic emergency, or by the Secretary of Defense 
+16 
+that there is a military emergency, or the declaration may be made if a material threat is identified under a particular provision of the Public Health Service Act. Typically, a diagnostic device may receive EUA-authorization on the basis of analytical and clinical studies that do not satisfy the requirements for clearance or approval. Devices also may be exempt from design controls and other quality requirements. An EUA for a device remains in effect until the Secretary of Health and Human Services, in consultation with the Secretary of Defense, determines that the circumstances justifying emergency use of the device no longer exist, or until the authorized device is approved or cleared. 
+If there are any modifications made to our marketed devices, a new premarket notification, PMA supplement, or request to change an EUA may be required to be submitted to, and cleared, approved, or authorized by, the FDA, before the modified device may be marketed. A new PMA or a PMA supplement is required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to the device’s intended use(s), manufacturing process, manufacturing facility, critical components, labeling and design. Likewise, a new 510(k) clearance is required for any modification that could significantly affect the safety or effectiveness of the device, e.g. a significant change or modification in design, material, chemical composition, energy source, or manufacturing process or a major change or modification in the intended use(s) of the device. 
+A clinical trial may be required in support of a 510(k) submission and generally is required for a de novo or PMA application. These trials generally require an approved application for an Investigational Device Exemption (“IDE”) and compliance with other IDE requirements, unless the proposed study is deemed to be exempt from the IDE requirements. An IDE application must be supported by appropriate data, such as laboratory testing results, protocols for the proposed investigation, and other information demonstrating that the device is appropriate for use with humans in a clinical study. Clinical trials may begin if the IDE application is approved by the FDA and the appropriate institutional review boards at the clinical trial sites. Submission of an IDE application does not give assurance that the FDA will issue the IDE. If the IDE application is approved, there can be no assurance the FDA will determine that the data derived from the trial(s) support the ultimate approval or clearance of the device or warrant the continuation of clinical trials. An IDE supplement must be submitted to and approved by the FDA before a sponsor or investigator may make a change to the investigational plan in such a way that may affect its scientific soundness, study indication or the rights, safety or welfare of human subjects. The trial must also comply with the FDA’s regulations, including the requirement that informed consent be obtained from each subject, and with clinical trial reporting regulations that require submission of information on certain clinical trials to a database maintained by the National Institutes of Health. Even if a trial is completed, the results of clinical testing may not adequately demonstrate the safety and efficacy of the device or may otherwise not be sufficient to obtain FDA clearance to market the product in the United States. If a study meets the requirements for a non-significant risk study, however, it may be eligible for compliance with “abbreviated” IDE requirements, which include a subset of the requirements applicable to significant risk medical device studies. A non-significant risk study also will be considered to have an approved IDE application without such application actually being submitted to FDA. 
+Some of our products are used for research only or other nonclinical or non-diagnostic purposes. Our molecular collection products are sold to many academic and research institutions for research purposes and our drugs-of-abuse products are sold to laboratories and clinics for forensic or other non-medical uses. The FDA does not currently regulate products used for these purposes, although other state and federal regulatory requirements may apply. 
+Most devices distributed in the United States must comply with the FDA’s Quality System Regulations (“QSRs”), including current good manufacturing practices. These regulations govern the entire lifecycle of a medical device, including design, manufacture, testing, release, packaging, distribution, documentation and purchasing as well as complaint handling, corrective and preventative actions, and internal auditing. In complying with the QSRs, manufacturers must continue to expend time, money and effort in the area of production, quality, and postmarket surveillance to ensure full compliance. 
+Companies that market devices are also subject to other post-market and general requirements, including product listing and establishment regulations, which help facilitate FDA inspections and other regulatory action, post-market surveillance requests, restrictions imposed on marketed products, promotional standards and requirements for recordkeeping and reporting of certain adverse reactions and device malfunctions. Device reporting regulations require that manufacturers report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur. 
+The FDA regularly inspects companies to determine compliance with the QSRs and other post-market requirements. Failure to comply with statutory requirements and the FDA’s regulations can result in an FDA Form 483 (which is issued by the FDA at the conclusion of an inspection when an investigator has observed any conditions that may constitute violations), public warning letters, monetary penalties against a company or its officers and employees, suspension or withdrawal of regulatory approvals, operating restrictions, total or partial suspension of production, injunctions, product recalls, product detentions, refusal to provide export certificates, seizure of products and criminal prosecution. We believe that our facilities and procedures are in material compliance with the FDA’s OSR 
+17 
+regulations and other postmarket requirements, but the regulations are subject to change or may be unclear, and we cannot be sure that FDA investigators will agree with our compliance with the FDA’s postmarket requirements. 
+The Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) prohibit any facility that conducts laboratory testing on specimens derived from humans from providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of human beings, unless there is in effect for such facility a certificate issued by the U.S. Department of Health and Human Services or an accredited organization, and such certificate is applicable to the category of examination or procedure performed. Tests may be categorized as “waived,” enabling them to be used by laboratories with the lowest level of CLIA oversight if the tests meet certain requirements established under CLIA. We consider the applicability of CLIA requirements in the design and development of our products. We have obtained a waiver of the CLIA requirements for our OraQuick ADVANCE ® rapid HIV-1/2 antibody test, our OraQuick ® HCV rapid antibody test and our Q.E.D. ® alcohol saliva test and may seek similar waivers for certain other products. In addition, the supplier of the OraSure Quick-Flu® test has obtained a CLIA waiver for that product. 
+The laboratory services provided by our subsidiary, Diversigen, are subject to CLIA and consist of microbiome and metagenomics sequencing, bioinformatics and analysis. Diversigen has recently received a CLIA certificate of registration in Minnesota, and is pursuing accreditation from the College of American Pathologists (CAP). A CLIA certificate of compliance is issued once a state regulator or the Center for Medicare and Medicaid Services determines that the laboratory is compliant with the applicable CLIA requirements. Under CLIA, certain organizations—including CAP—can accredit laboratories performing testing on specimens from human beings or animals, using methodologies and clinical applications within the expertise of the laboratory accreditation program. 
+Certain of our products may also be affected by state regulations in the United States, which can restrict the use and sale of certain diagnostic products. We are presently working with legislators or regulators in certain of these states in an effort to modify or remove any restrictions affecting our ability to sell products. 
+Advertising and Promotion 
+Advertising and promotion of medical devices, in addition to being regulated by the FDA, are also regulated by the Federal Trade Commission (“FTC”) and by other federal and state regulatory and enforcement authorities, including the Department of Justice (“DOJ”), the Office of Inspector General of the Department of Health and Human Services, and various state attorneys general. Although physicians are permitted to exercise medical judgment to use medical devices for indications other than those cleared or approved by the FDA, we may not promote our products for such “off-label” uses and can only market our products for cleared or approved uses. Promotional activities for FDA-regulated products of other companies have also been the subject of enforcement actions brought under healthcare reimbursement laws and consumer protection statutes. In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims. If the FDA determines that our promotional materials or training constitute promotion of an uncleared or unapproved use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a notice of violation, a warning letter, injunction, seizure, civil fine or criminal penalties. FTC enforcement actions often result in consent decrees that constrain future actions. DOJ prosecutions can result in significant criminal and civil penalties, including exclusion from the Medicare and Medicaid programs. If an enforcement action is brought by the FDA or FTC, our reputation could be damaged and sales of our products could be impaired. 
+Import and Export Requirements 
+Products for export from the United States are subject to foreign countries’ import requirements and the exporting requirements of the FDA, as applicable. In particular, international sales of medical devices manufactured in the United States that are not approved or cleared by the FDA for use in the United States, or are banned or deviate from lawful performance standards, are subject to FDA export requirements. 
+Foreign countries often require, among other things, an FDA certificate for products for export, also called a Certificate for Foreign Government (“CFG”). To obtain this certificate from the FDA, the device manufacturer must apply to the FDA. The FDA certifies that the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with QSR regulations at the time of the last FDA inspection. If the FDA determines that our facilities or procedures do not comply with the QSR regulations, it may refuse to provide such certificates until we resolve the issues to the FDA’s satisfaction. Failure to obtain a CFG could inhibit our ability to export our products to countries that require such certificates. 
+18 
+International 
+We are also subject to regulations in foreign countries governing products, human clinical trials and marketing, and may need to obtain approval (or pre-qualification or endorsement) from local regulators in such countries or international public health agencies, such as the World Health Organization, in order to sell products in certain countries. Approval processes vary from country to country, and the length of time required for approval or to obtain other clearances may in some cases be longer than that required for U.S. governmental approvals. We generally pursue approval only in those countries that we believe have a significant market opportunity. 
+The International Organization for Standardization (“ISO”) is a worldwide federation of national standards bodies from some 130 countries, established in 1947. The mission of the ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services. ISO 13485 certification indicates that our quality system complies with standards applicable to activities ranging from initial product design and development through production and distribution. 
+In the European Union (“EU”), products that fall under the scope of the Medical Devices Directive (“MDD”) and the In Vitro Diagnostic Medical Devices Directive (“IVDD”) are not subject to the prior approval of a regulatory authority, but, depending on the class of product, may require prior review by a notified body. Notified bodies are accredited and supervised by national regulatory authorities to conduct conformity assessment procedures of medical devices or other products. Such products must comply with certain essential requirements listed in those directives. ISO certification creates a rebuttable presumption that the product satisfies the applicable requirements. Compliance with these requirements allows us to complete the applicable conformity assessment procedure, involving a notified body where necessary, and to affix the CE mark to our products, without which they may not be placed on the market in the EU. 
+In addition, the EU has adopted the EU Medical Devices Regulation (the “EU MDR”) and the In Vitro Diagnostic Medical Devices Regulation (the “EU IVDR”), which will repeal and replace the MDD and IVDD. The EU MDR and EU IVDR impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance. Manufacturers of currently approved medical devices will have until May 2021 to meet the requirements of the EU MDR and until May 2022 to meet the EU IVDR. Compliance with these regulations may be expensive and time-consuming. Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements. We also note that from January 1, 2021, the United Kingdom (“UK”) has introduced a UK-specific route to market for medical devices. Compliance with these requirements may add further complexities to our international strategy. 
+We must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in Canada. We have completed this process for several of our current products and may do so with respect to other products in the future. In addition, Canadian law requires manufacturers of medical devices to have a quality management system that meets various ISO requirements in order to obtain a license to sell their devices in Canada. Health Canada also requires all companies that market Class II, Class III and Class IV products in Canada to be certified as part of the Medical Device Single Audit Program (MDSAP). We received this certification for our Diagnostics segment (previously named “OSUR”) in June 2019. 
+We have obtained WHO pre-qualification for our OraQuick ® HIV Self-Test and OraQuick ® HCV test and we will likely seek WHO pre-qualification or endorsement for certain other products sold into international markets. 
+Anti-Kickback and Other Fraud and Abuse Laws 
+The Federal Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation, or receipt of any form of remuneration in return for, or to induce: 
+• 
+The referral of an individual to a person for the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other governmental healthcare programs; or 
+• 
+The purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of any item or service reimbursable under Medicare, Medicaid, or other governmental healthcare programs. 
+Our products are or may be purchased by customers that will seek or receive reimbursement under Medicare, Medicaid or other governmental healthcare programs. Noncompliance with the Federal Anti-Kickback Statute can result in exclusion from Medicare, Medicaid or other governmental healthcare programs, and/or restrictions on our ability to operate in certain jurisdictions, as well as civil and criminal penalties, any of which could have an adverse effect on our business and results of operations. 
+19 
+The False Claims Act (“ FCA ”) , imposes liability on any person or entity who, among other things, knowingly and willfully presents, or causes to be presented, a false or fraudulent claim for payment by a federal health care program, including Medicaid and Medicare. A violation of the Federal Anti-Kickback Statute is considered a violation of the FCA. Some suits filed under the FCA, known as “qui tam” actions, can be brought by a “whistleblower” or “relator” on behalf of the government, and such individuals may share in any amounts paid by the entity to the government in fines or settlement. Manufacturers can be held liable under false claims laws, even if they do not submit 
+The Federal Civil Monetary Penalties Law prohibits the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services. Noncompliance can result in civil monetary penalties for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion from the Federal healthcare programs. 
+Many states have also adopted some form of anti-kickback laws and false claims laws. A determination of liability under such laws could result in fines and penalties, restrictions on our ability to operate in these jurisdictions and significant damage to our reputation. 
+We are also subject to other federal and state laws targeting fraud and abuse in the healthcare industry, including marketing conduct laws, transparency laws, and laws that require us to adopt a compliance program. Taken together, these fraud and abuse laws constrain the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements, including sales programs, such manufacturers can enter into with physicians, hospitals, laboratories and other potential purchasers of medical devices. Violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in government healthcare programs such as Medicare and Medicaid. These laws and regulations are wide ranging and subject to changing interpretation and application. In recent years, there has been greater scrutiny of marketing practices in the medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare providers. For example, under the Sunshine Act provisions of the Affordable Care Act, device manufacturers are subject to federal reporting and disclosure requirements with regard to payments or other transfers of value made to health care providers. Reports submitted under the Sunshine Act are placed in a public database. Device manufacturers are required to submit annual reports by March 31 which cover the prior calendar year. To be in compliance with such disclosure laws, we have implemented necessary systems to accurately track gifts and other payments. 
+We have implemented a written Policy on Interactions with Health Care Professionals, which is based on the Code of Conduct for Interactions with Health Care Professionals promulgated by the Advanced Medical Technology Association, or AdvaMed, a leading trade association representing medical device manufacturers. The Policy applies to all employees and is intended to comply with applicable state and federal laws, regulations and government guidance. The Policy addresses interactions related to sales and marketing practices, research and development, product training and education, grants and charitable contributions, support of third-party educational conferences, and consulting arrangements. While we believe that our practices are in compliance with the Anti-Kickback and other fraud and abuse laws, the standards for compliance with such statutes can be unclear and subject to change. 
+Foreign Corrupt Practices Act and Other Anti-Corruption Laws 
+The U.S. Foreign Corrupt Practices Act (“FCPA”), to which we are subject, prohibits corporations and individuals from engaging in bribery and corruption when dealing with foreign government officials and foreign political parties. It is illegal to corruptly offer, pay, promise, or authorize the giving of anything of value to any officer or employee of a foreign government or public international organization, political party, political party official, or political candidate, in an attempt to obtain or retain business or to otherwise improperly influence a person working in an official capacity on behalf of a foreign government or public international organization. Our present and future business has and will continue to be subject to the FCPA and various other laws, rules and/or regulations applicable to us as a result of our international sales. We also are subject to the FCPA’s accounting provisions, which require us to keep accurate books and records and to maintain a system of internal accounting controls sufficient to assure management’s control, authority, and responsibility over the company's assets. The failure to comply with the FCPA and similar laws could result in civil or criminal sanctions or other adverse consequences. 
+The laws to which we are subject as a result of our international sales also include the U.K. Bribery Act (the “Bribery Act”), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official, and failing to have adequate procedures to prevent employees and other agents from giving bribes. U.S. companies that conduct business in the United Kingdom generally will be subject to the Bribery Act. Penalties under the Bribery Act include potentially unlimited fines for companies and criminal sanctions for corporate officers under certain circumstances. 
+20 
+Environmental Regulation 
+Because of the nature of our current and proposed research, development, and manufacturing processes, we are subject to stringent federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge and handling and disposal of solid wastes, hazardous materials and hazardous wastes. Products that we sell in Europe are subject to regulation in European Union, or EU, markets under the Directive on the Restriction of the Use of Certain Hazardous Substances (“RoHS”). RoHS prohibits companies from selling electrical and electronic equipment, such as electronic medical devices, that contain certain hazardous materials, including lead, mercury, cadmium, chromium, polybrominated biphenyls and polybrominated diphenyl ethers, in the EU Member States. In addition, the EU’s Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) imposes severe restrictions and requirements on companies marketing devices in the EU. Among other things, REACH requires companies to obtain prior authorization to use substances of very high concern that are listed for authorization, and imposes bans on the marketing of products that contain specifically listed hazardous substances. Companies marketing medical devices in the EU may also be subject to expensive waste take back obligations under the EU Directive on Waste Electrical and Electronic Directive, the Packaging and Packaging Waste Directive, and the Batteries Directive. 
+Future environmental laws, rules, regulations or policies may require us to alter our manufacturing processes, thereby increasing our manufacturing costs, or may impose other additional obligations on us or our products. We believe that our products and manufacturing processes at our facilities comply in all material respects with applicable environmental laws and worker health and safety laws; however, the risk of environmental liabilities cannot be completely eliminated. 
+The foregoing discussion of our business should be read in conjunction with the consolidated financial statements and accompanying notes included in Item 15 of this Annual Report. 
+21

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+ITEM 13. 
+Certain Relationships and Related Transactions, and Director Independence. 
+The information required by this Item is incorporated by reference to the information under the captions “Transactions with Related Persons” and “Corporate Governance - Director Independence” in the Proxy Statement.

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+ITEM 9A. 
+Controls and Procedures. 
+(a) Evaluation of Disclosure Controls and Procedures . 
+The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2020. Based on that evaluation, the Company’s management, including such officers, concluded that as of December 31, 2020 the Company’s disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by the Company in the reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to the Company’s management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure and is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. 
+(b) Management’s Report on Internal Control Over Financial Reporting. 
+The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934. Under the supervision and with the participation of the Company’s management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework, our management concluded that our internal control over financial reporting was effective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles as of December 31, 2020. 
+Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 
+The Company acquired UrSure, Inc. during 2020, and management excluded from its assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2020, the acquired company representing approximately 1.7% of total assets and 0.5% of total revenues of the Company as of and for the year ended December 31, 2020. Management plans to fully integrate the operations of these businesses into the assessment of the effectiveness of the Company’s internal control over financial reporting in 2021. 
+The effectiveness of our internal control over financial reporting as of December 31, 2020 has been audited by KPMG LLP, an independent registered public accounting firm, as stated in their report, which is included below. 
+(c) Changes in Internal Control Over Financial Reporting . 
+There were no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 
+(d) Report of Independent Registered Public Accounting Firm . 
+To the Stockholders and Board of Directors 
+OraSure Technologies, Inc.: 
+Opinion on Internal Control Over Financial Reporting 
+We have audited OraSure Technologies, Inc. and subsidiaries' (the Company) internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. 
+We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2020 and 2019, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the three-year period ended 
+62 
+December 31, 2020, and the related notes (collectively, the consolidated financial statements), and our report dated March 1, 2021 expressed an unqualified opinion on those consolidated financial statements. 
+The Company acquired UrSure, Inc. during 2020, and management excluded from its assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2020, UrSure, Inc.’s internal control over financial reporting associated with approximately 1.7% of total assets and 0.5% of total revenues included in the consolidated financial statements of the Company as of and for the year ended December 31, 2020. Our audit of internal control over financial reporting of the Company also excluded an evaluation of the internal control over financial reporting of UrSure, Inc. 
+Basis for Opinion 
+The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. 
+We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. 
+Definition and Limitations of Internal Control Over Financial Reporting 
+A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. 
+Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 
+/s/ KPMG LLP 
+Philadelphia, Pennsylvania 
+March 1, 2021

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