About OraSure Technologies

OraSure Technologies, Inc. (OraSure) develops, manufactures, markets and sales of diagnostic products and specimen collection devices. In 2022, the company’s business previously consisted of two segments: ‘Diagnostics’ segment and ‘Molecular Solutions’ segment. In February 2023, the company announced a corporate restructuring to combine the commercial and innovation teams across the two segments into one business unit with sales, marketing, product development and research teams covering multiple product lines. Diagnostics Business The company’s Diagnostics business primarily consists of the development, manufacture, marketing and sale of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products, including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Diagnostics business includes tests for diseases, including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse 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. The company’s COVID-19 and HIV products are also sold in a consumer-friendly format in the over the counter (OTC) market in the U.S. and, in the case of the HIV product, as a self-test to individuals in a number of other countries. In 2022, after obtaining a CE mark, the company launched its OraQuick HIV Self-Test, an oral swab in-home test for HIV-1 and HIV-2, in Europe, making it available in several European countries. Through the company’s Diagnostics business it is also developing and commercializing products that measure adherence to HIV medications, including pre-exposure prophylaxis (PrEP). In September 2022, the company entered into an agreement with the Biomedical Advanced Research Development Authority (BARDA), pursuant to which BARDA will provide funding to it to develop a 2nd generation Ebola test on the OraQuick testing platform, with the objective of developing increased sensitivity and shelf life, with new chemistry and higher degrees of automation in the test’s manufacturing process. Molecular Solutions The company’s Molecular Solutions business is operated by its wholly-owned subsidiaries, DNA Genotek Inc, Diversigen, and Novosanis. The company’s Molecular Solutions business sells its products and services directly to its customers, primarily through its internal sales force in the U.S. domestic market, and in many international markets, and also through distributors. The company’s products primarily consist of collection kits and services used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. Most of the company’s Molecular Solutions revenues are derived from product sales to commercial customers and sales into the academic and research markets. Molecular Solutions customers span the disease risk management, diagnostics, pharmaceutical, biotech, nutrition, companion animal and environmental markets. In 2020, the company expanded the market focus of its Molecular Solutions business by selling existing collection products for use with COVID-19 tests. In 2022, demand for COVID-19 PCR testing declined, which was primarily driven by the availability of antigen tests, the reduction in the numer of COVID-19 cases, and the wider availability of vaccines that negatively impacted the sales of the collection products. The company has also developed additional collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. In 2022, the company launched the OMNIgene GUT Dx collection device (OMD-200), which was granted De Novo authorization from the U.S. Food and Drug Administration (FDA) for collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene·GUT Dx device. Additionally, the company’s OMNIgene GUT DNA and RNA collection device (OMR-205), became available to gut microbiome researchers, allowing for self-collection, stabilization, storage and transportation of microbial DNA and RNA at ambient temperature for gut microbiome profiling. The company leverages its existing sales force and global research connections to engage microbiome customers worldwide to establish itself among the leaders in ease-of-collection, stabilization, and transport of this challenging sample type. Through the company’s partnership with Grifols, it received FDA clearance for its ORAcollect Dx saliva collection device for over-the-counter (OTC) use, which allows its commercial partners to use and market the device with their therapeutics or devices. The company’s Molecular Solutions products include the Colli-Pee device, developed and sold by its Novosanis NV (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 in the liquid biopsy and sexually transmitted disease markets. In 2022, Novosanis obtained a CE mark for its Colli-Pee device containing a prefilled tube with UAS chemistry, which is designed to stabilize urinary analytes. The company’s Diversigen, Inc. (Diversigen) subsidiary also offers laboratory and analytical services for both genomics and microbiome customers to more fully meet their needs. These services are primarily provided to pharmaceutical, biotech companies, and research institutions. In 2022, Diversigen launched its metatranscriptomics sequencing and analysis services for gut microbiome samples, which generate a microbial community’s gene expression profile to provide information about the interactions between an individual and their microbiome, creating a holistic picture of a sample’s microbial functions and expression levels. Business Update Related to InteliSwab Covid-19 Rapid Tests In June 2021, the company received three Emergency Use Authorizations (EUA) from the FDA for its InteliSwab COVID-19 Rapid Tests (InteliSwab) for non-prescription OTC, professional point-of-care use and prescription home use. The company began recording revenues on the sales of its InteliSwab tests during the third quarter of 2021. In January 2022, InteliSwab received FDA authorization for pediatric use in children ages 2 to 14. In September 2021, the Defense Logistics Agency (DLA) awarded the company a procurement contract for the InteliSwab tests for OTC use, which will provide InteliSwab tests to up to 20,000 sites throughout the United States. In 2022, the company began to deliver tests to sites throughout the United States under this contract, and DLA has provided delivery orders against which it can continue to issue shipping instructions into 2023. In November 2022, the DLA awarded it a second procurement contract for the InteliSwab tests for OTC use. Under the terms of the award, the contract estimate is 18 million tests, with a maximum award of 36 million tests and a guaranteed minimum award of 3.6 million tests. The contract will run from November 2022 through November 2023. In December 2022, the U.S. Department of Health and Human Services (HHS) awarded the company a fully funded firm fixed price contract for a total of 3.2 million InteliSwab tests which were delivered in February 2023. In September 2021, the company entered into an agreement with BARDA, which is part of the office of the Assistant Secretary for Preparedness and Response at HHS, pursuant to which BARDA would provide the company with funding to obtain clearance of a premarket notification (510(k)) and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver of the InteliSwab tests. In May 2022, InteliSwab was selected by HHS to be distributed across the United States for nationwide school testing. Through 2022, the company has scaled up its operations to meet the increased demand for the InteliSwab tests. The company significantly expanded its United States production capacity for InteliSwab tests to achieve capacity targets, set out in its 2021 contract with the U.S. Department of Defense (DOD) (in coordination with the HHS), of more than 100 million tests annually. Diagnostics Products The following is a summary of the company’s principal Diagnostics products for the infectious disease and risk management markets: InteliSwab COVID-19 Rapid Test InteliSwab is the company’s rapid immunoassay product designed to test nasal samples for the presence of antigen from SARS-CoV-2. The device uses an integrated swab to collect a specimen from the lower nostril. After collection, the integrated swab is inserted into a vial containing a pre-measured amount of developer solution to facilitate flow of the sample into the device. The specimen and developer solution flow through the test device and test results are observable in 30 minutes. The InteliSwab test has received Emergency Use Authorizations (EUA) from the FDA for non-prescription, OTC home use in individuals aged two years or older, with symptoms within the first seven (7) days of onset when tested at least twice over a three-day period with at least 48 hours between tests and without symptoms or epidemiological reasons to suspect COVID-19 when tested at least three times over a five-day period with at least 48 hours between tests. In 2022, the InteliSwab test became available for purchase on Amazon’s online store to customers in the United States. The tests are sold and orders fulfilled by Amazon. InteliSwab COVID-19 Rapid Test Pro The InteliSwab COVID-19 Rapid Test Pro is a version of InteliSwab intended for use by healthcare providers at the point of care. The test is performed in the same manner as the OTC version, except that the test is run and interpreted by a healthcare provider. This test has received EUA from the FDA for use by laboratories located in the United States certified under CLIA. The company has also received a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for use of the test, which enables the test to be used by numerous additional sites in the United States, which are not certified under CLIA, to perform high and moderately complex tests. These additional sites include outreach clinics, community-based organizations and physicians’ offices. This test is also indicated for individuals aged 2 years and older, with and without symptoms of COVID-19. InteliSwab COVID-19 Rapid Test Rx The InteliSwab COVID-19 Rapid Test Rx is the version of InteliSwab that has received EUA from the FDA for prescription home use with individuals aged 2 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven days of symptom onset. OraQuick Rapid HIV Test The OraQuick Rapid HIV Test is the company’s rapid point-of-care test product designed to test oral fluid, whole blood (i.e., both finger-stick and venous), plasma and serum samples for the presence of various antibodies. 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. 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 approval of a premarket approval (PMA) application 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 CLIA, to perform moderately complex tests. The company has 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, the company has obtained a CE mark for its OraQuick ADVANCE test so that it 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. The company has distributors in place for several countries and are seeking to increase awareness and expand its distribution network for this product throughout the world. The company has also received World Health Organization (WHO) pre-qualification for its 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 the company’s OraQuick ADVANCE HIV 1/2 Antibody Test. The company received PMA approval to sell this test in the U.S. OTC market. 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, the company has 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, including under the CE mark in certain European countries, 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. The company has received FDA PMA 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 The company has received 510(k) clearance from the FDA for its 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. In September 2022, the company entered into an agreement with BARDA, pursuant to which BARDA will provide funding to it to develop a 2nd generation Ebola test on the OraQuick testing platform. OraSure Collection Device The company’s 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, a serum-derived fluid that contains higher concentrations of certain antibodies and analytes than saliva. As a result, oral mucosal transudate 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 for oral fluid drug testing. The company has 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. The company’s Intercept device and oral fluid assays are sold in the U.S. primarily through laboratory distributors. The company has also developed a next-generation collection device, which it is marketing under the trade name Intercept i2 he. This device offers several important advantages over its 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 laboratory testing protocols and a more optimized chemistry that results in improved recovery of the targeted drug analytes. The Intercept i2 he device is 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 the company distributes under an agreement with Thermo Fisher Scientific. Immunoassay Tests and Reagents The company develops and sells immunoassay tests in formats, known as MICRO-PLATE and AUTO-LYTE, to meet the specific needs of its customers. The company also sells fully-automated high-throughput oral fluid drug assays developed under its agreement with Thermo Fisher. The company’s 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 it is selling a NIDA-5 panel of microplate assays supplied by Thermo Fisher to the U.S. forensic market under the agreement. 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. Q.E.D. Saliva Alcohol Test The company’s Q.E.D. saliva alcohol test is a point-of-care test device that is an 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 Products Genomic Products The company sells many genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA, RNA, as well as both DNA and RNA together from human and animal biological samples. The company’s lead products are sold under the Oragene and ORAcollect brands and are used to collect genetic material from human saliva. These products are sold to thousands of academic research and commercial customers in many countries worldwide. In 2022, the company received FDA clearance for its ORAcollect Dx saliva collection device for OTC use through its partnership with Grifols, which allows its commercial partners to use and legally market the device with their assays when used in conjunction with their intended uses. The company’s genomic products are available in several configurations and contain proprietary chemical solutions 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 hold the product close to their mouth and spit into the collection device. When the container is closed, the reagents stored in the container’s lid are mixed with the captured saliva and stabilize and preserve 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 ensures the preservation of high quality and high quantity nucleic acids required for many genetic testing and analysis methods. The company also sells 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 Collection Products Since 2020, the company has actively engaged with several laboratories and researchers to demonstrate the effectiveness of its existing collection products for use with COVID-19 molecular testing. Oral samples collected using devices from the company’s 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. As a result, since 2020, the company has sold its ORAcollect RNA and OMNIgene ORAL collection devices for use in connection with COVID-19 molecular testing. Due in part to the reduction in the number of COVID-19 cases and the shift toward the use of antigen testing, the demand for COVID-19 PCR testing declined in 2022, which negatively impacted the sales of the company’s collection products. Microbiome Products The company also markets several microbiome collection products designed to collect, stabilize, and transport the microbial profile from multiple sample types. When unstabilized, a microbiome sample can change when exposed to environmental fluctuations, such as temperature changes. The company’s microbiome collection products support collecting and stabilizing metabolites found in fecal samples by capturing and preserving the microbiome after collection until the desired analysis can be performed. The company’s 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 the clinical laboratory and research settings. In 2022, the company’s OMNIgene GUT DNA and RNA collection device (OMR-205), became available to gut microbiome researchers, allowing for self-collection, stabilization, storage and transportation of microbial DNA and RNA at ambient temperature for gut microbiome profiling. Most current methodologies for gut microbiome profiling have distinct shortcomings due to the introduction of bias, leading to a lack of reproducibility in the field. The company’s product ensures that the microbial DNA and RNA in the fecal sample are fully stabilized immediately upon collection and maintains an accurate and reliable bacterial profile for weeks at room temperature. The company has applied these principles of sample stabilization to other sample types, including oral, skin, and vaginal samples. The company also launched the OMNIgene GUT Dx collection device (OMD-200), which was granted De Novo authorization from the FDA for collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene·GUT Dx device. Laboratory and Data Analytical Services The company’s Molecular Solutions business also offers its customers microbiome laboratory testing and analytical services. The company’s services focus on accelerating microbiome discovery for customers in the pharmaceutical, agriculture, and research communities. The company also offers comprehensive microbiome and metagenomics services to improve human, animal, and environmental health and, in 2022, the company launched its metatranscriptomics sequencing and analysis services for gut microbiome samples. These services generate a microbial community’s gene expression profile to provide information about the interactions between an individual and their microbiome, creating a holistic picture of a sample’s microbial functions and expression levels. Diversigen has extensive experience with highly diverse microbiome sample types and provides complete project life cycle consulting services, including pre-project consulting, study design, extraction, and sequencing to complete bioinformatics analysis. Diversigen is at the forefront of setting quality standards for this industry and has obtained the College of American Pathologists (CAP) accreditation at its laboratory facilities. Products Under Development Diagnostic Products The company’s research and development efforts include programs targeted at expanding and enhancing its diagnostics business. These programs typically focus on products related to drug adherence and rapid tests for various diseases. The company is working to develop a 2nd generation Ebola test on the OraQuick testing platform with funds obtained under its contract with BARDA. Molecular Solutions In order to intersect evolving customer needs within the academic and commercial markets, the company’s 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 collection and stabilization of cell-free nucleic acids, exosomes, DNA and RNA. On the microbiome front, the company continues 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. The field of microbiome services is fast paced with evolving biological understanding and development of new methodologies. The company’s development efforts are focused on remaining at the forefront of laboratory and informatics technologies, as well as providing new and relevant services to the company’s customers. These include a focus on laboratory and informatics methods to integrate DNA, RNA and metabolites from microbial communities across different sample types. Sales and Marketing The company markets its products in the United States and internationally. The company attempts to reach its major target markets through a combination of direct sales, strategic arrangements and independent distributors. The company’s 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. Diagnostics - Professional The company’s InteliSwab COVID-19 Rapid Test Pro and Rx products are primarily sold through distributors to the U.S. hospitals, physician offices and clinics. These products are also marketed directly to customers in the public health market, including clinics and laboratories of state, county and other governmental agencies. The company markets 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. The company sells its OraQuick ADVANCE test to hospitals and physician offices in the U.S. primarily through distributors. In addition, the company distributes its OraQuick HIV test in certain foreign countries through distributors. The company’s OraQuick HCV test is sold primarily to the same markets where its OraQuick ADVANCE HIV test is sold, including public health organizations, hospitals, physicians and retail clinics. The company also sells this test in other countries through distributors. Diagnostics - OTC and Self-Test The company sells its InteliSwab COVID-19 Rapid Test product in the U.S. retail and consumer markets, including for purchase by the U.S. customers on Walmart and Amazon’s online stores. The OTC InteliSwab test is also sold directly and through distributors into a broad range of business-to-business (B2B) markets, including employer testing, colleges and universities, local, state and federal governmental agencies and the U.S. military. The company sells its OraQuick In-Home HIV test in the U.S. retail or consumer market. The product is also available for purchase on-line through certain retailers and from its website, www.oraquick.com. The primary target population for the company’s 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. The company also sells its OraQuick HIV Self-Test in certain international markets. The company’s 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 the company’s test. Substance Abuse Testing The company’s 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. The company has entered into agreements for the distribution of its 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. The company also markets the Intercept collection device on its own and as a kit in combination with laboratory testing services. To better serve its workplace customers, the company has 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 the company’s 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. The company also sells its next generation Intercept i2 he 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 sold into the criminal justice and drug treatment markets. The company distributes its 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 The company’s Molecular Solutions business sells its products directly to its customers, primarily through its own internal sales force in the U.S. domestic markets. However, in many international markets, distributors are used. Most of the company’s Molecular Solutions revenues are derived from product sales to commercial customers and sales into the academic and research markets. The company’s commercial customers provide consumer genetics and clinical diagnostic services and account for a majority of these revenues. A significant portion of total sales are derived from repeat customers in both markets. Molecular Solutions also has customers in the livestock, companion animal and pharmaceutical markets. The company has expanded the market focus of its Molecular Solutions business by selling certain existing collection products for use in infectious disease testing, including COVID-19 tests, and by developing new collection devices for the emerging microbiome market, which is focused on the study of microbial communities and their effect on human health. The company’s primary product offering in the microbiome market, OMNIgene GUT, is focused on the human gut microbiome (microbes living in human stool). The company is leveraging its existing sales force and global research connections to engage microbiome customers around the world and establish itself as among the leaders in ease-of-collection, stabilization and transport of microbiome communities in a variety of challenging sample types, such as stool, skin, vaginal and oral. The company’s Molecular Solutions products include the Colli-Pee device, a product developed and sold by its 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. The company also offers 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, the company substantially expanded its 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 under the Diversigen brand. Supply and Manufacturing The fully-automated high-throughput oral fluid drug assays sold with the company’s new Intercept i2 he collection device are manufactured and supplied under a long-term agreement with Thermo Fisher. The company’s genomic, microbiome and metatranscriptomics laboratory testing and analytical services are provided by its subsidiary, Diversigen. Patents and Proprietary Information The company has patents throughout its product and service lines. The company’s patent portfolio includes pending applications and issued patents in diagnostics and testing, sampling tools, and services and analysis. The company’s portfolio protects its innovative sampling tools, services and diagnostics that provide access to accurate, essential information that advances global health and well-being. Diagnostics and testing products include the OraSure and Intercept collection devices that are covered by one utility and one design patent in each of the U.S., Canada, Japan, and throughout Europe. The company has numerous foreign patents for its collection devices and technology relating to oral fluid collection, containers for oral fluids, methods to test oral fluids, and methods to control the volume of oral fluids collected and dispersed. The utility patents will expire in January 2028, and the design patents will expire in 2025. Sampling tools are the subject of several other patents and pending applications, including the U.S. and international utility patent applications directed to a new oral fluid collection device. The international applications will enter their national phase in countries throughout the world beginning in October 2023. Patents issuing from these applications will expire in March 2041. The company has a U.S. and international PCT patent applications that are directed to a new developer solution vial for use with sampling and assay devices. The international application and will enter its national phase in countries throughout the world, beginning in May 2023 and patents issuing from these applications will expire in December 2041. Related design patent applications are pending in the U.S., Canada, and Europe. The company has additional pending applications directed to new direct sample collection pads for its InteliSwab COVID-19 Rapid Test. These applications will enter their national phase in countries throughout the world, beginning in October 2023, and patents issuing from these applications will expire in December 2042. A related design patent issued in 2022 in the U.S. and corresponding design applications were registered in Canada, China, India, and Europe. These design patents will expire 2035. The company has registered design patents for a collection funnel and corresponding plunger device in Europe, China, and India and a corresponding the U.S. design patent application is pending. The company has pending patent applications throughout its product and service lines directed to assays, methods, devices, and reagents for monitoring adherence to HIV medications, such as nucleoside reverse transcriptase inhibitors used in PrEP regimens. The company has two international families of patent applications filed in the United States and in numerous countries worldwide. These applications are directed to novel nucleoside reverse transcriptase inhibitor-specific antibodies for use in assays to detect the presence of nucleoside reverse transcriptase inhibitor drug derivatives, including tenofovir, in fluid samples. Patents issuing from these applications will expire in October 2038 and December 2040. The company hold, through its subsidiary, DNA Genotek Inc. (DNAG), thirty 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 June 2023 through October 2037. The company holds through its subsidiary, Novosanis, one granted United States patent and numerous foreign patents covering a medical device for capturing a predetermined volume of first void urine. This patent expires in September 2033. The company has also applied for additional patents, in both the United States and certain foreign countries, in novel urine collection devices. The company’s 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 sample containing polynucleotide molecules. These patents will expire in May 2036. 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. The company owns rights to trademarks and service marks that are necessary to conduct its business as operated. In the United States, the company owns a number of trademarks, including the OraSure, Intercept, Intercept i2 he, OraQuick, OraQuick ADVANCE, OraSure QuickFlu, Q.E.D., InteliSwab, Oragene, DNA Genotek, OMNImet, ORAcollect, OMNIgene, goDNA, Diversigen, CoreBiome, Boostershot, MetaGene, Benchmark, Novosanis, Colli-Pee, UCM, UAS, AUTO-LYTE, prepIT, and Hemagene trademarks. The company also owns many of these marks and others in several foreign countries and it is pursuing registration of several other trademarks. Government Regulation Most of the company’s products are regulated by the FDA, along with other federal, state and local agencies and comparable regulatory bodies in other countries. Many of the company’s 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, the company must continue to comply with other FDA requirements applicable to marketed products and is subject to periodic inspections by the FDA and other regulatory bodies. The company must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in Canada. Products that the company sells in Europe are subject to regulation in European Union markets under the Directive on the Restriction of the Use of Certain Hazardous Substances (RoHS). The U.S. Foreign Corrupt Practices Act (FCPA), to which the company is subject, prohibits corporations and individuals from engaging in bribery and corruption when dealing with foreign government officials and foreign political parties. The laws to which the company is subject as a result of its international sales also include the U.K. Bribery Act (the Bribery Act). The laboratory services provided by the company’s subsidiary, Diversigen, consist of microbiome, metatranscriptomics and metagenomics sequencing, bioinformatics and analysis. Diversigen has elected to obtain a license from CLIA and has received a certificate of accreditation from the College of American Pathologists (CAP). History OraSure Technologies, Inc. was founded in 2000. The company was incorporated in 2000.