OraSure Technologies, Inc., together with its subsidiaries, develops, manufactures, markets, and sells oral fluid diagnostic products and specimen collection devices in the United States, Europe, and internationally. It operates in two segments, Diagnostics and Molecular Solutions. The company's principal products include InteliSwab COVID-19 rapid test, InteliSwab COVID-19 rapid test pro, InteliSwab COVID-19 rapid test rx, OraQuick Rapid HIV test, OraQuick In-Home HIV test, OraQuick HIV self-test, OraQuick HCV rapid antibody test, OraQuick Ebola rapid antigen test, OraSure oral fluid collection device used in conjunction with screening and confirmatory tests for HIV-1 antibodies; Intercept drug testing systems; immunoassay tests and reagents; and Q.E.D. saliva alcohol test. It also offers genomic products under the Oragene and ORAcollect brands; microbiome collection products; and GenoFIND genomics laboratory services. In addition, the company provides ORAcollect, RNA and OMNIgene, and RAL collection devices for use in connection with COVID-19 molecular testing; offers Colli-Pee collection device for the volumetric collection of first void urine; and manufactures and sells kits that are used to collect, stabilize, transport, and store samples of genetic material for molecular testing in the academic research and commercial applications, including ancestry, disease risk management, lifestyle, and animal testing. Further, it provides other diagnostic products, such as immunoassays and other in vitro diagnostic tests. The company markets its products to clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. OraSure Technologies, Inc. was incorporated in 2000 and is headquartered in Bethlehem, Pennsylvania.
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Here are 1-2 brief analogies for OraSure Technologies (OSUR):
- Like a specialized Abbott Laboratories focused on rapid, non-invasive diagnostic tests.
- Imagine a more focused Thermo Fisher Scientific that develops diagnostic tools and unique sample collection technologies.
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- OraQuick® HIV Tests: Rapid oral fluid tests for the detection of HIV-1 and HIV-2 antibodies, available for both professional and self-testing use.
- InteliSwab™ COVID-19 Rapid Test: A self-administered rapid antigen test that provides accurate results for the qualitative detection of SARS-CoV-2.
- Oral Fluid Collection Devices (e.g., OraSure® Intercept®): Non-invasive devices for collecting oral fluid samples, primarily used in drugs of abuse testing.
- Molecular Sample Collection Devices (e.g., OMNIgene®, ORAcollect®): Non-invasive devices designed for collecting and stabilizing DNA, RNA, and microbial samples for genomics and diagnostics.
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OraSure Technologies (OSUR) primarily sells its diagnostic products and molecular collection devices to other companies and organizations rather than directly to individuals. While the company does not disclose specific major customer names in its public filings, as no single customer accounts for 10% or more of its consolidated net revenues, its major customer categories include:
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Healthcare Providers and Clinical Laboratories
This category encompasses hospitals, clinics, physicians' offices, and clinical laboratories. These customers utilize OraSure's range of diagnostic tests (e.g., for HIV, HCV, and COVID-19) and molecular sample collection devices for patient care, screening, and comprehensive diagnostic testing.
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Public Health and Government Entities
This includes various public health organizations, government agencies, and community-based organizations. These entities leverage OraSure's products for disease surveillance, public health programs, large-scale testing initiatives, and in institutional settings such as correctional facilities.
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Research Institutions and Biotechnology Companies
Through its Molecular Solutions division (DNA Genotek, Diversigen), OraSure provides advanced sample collection devices and specialized genomics/microbiome services. Its customers in this category include academic research institutions, pharmaceutical companies, and other biotechnology firms engaged in scientific studies, clinical trials, and research and development.
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Distributors and Retail Channels
OraSure also distributes its products through a network of other distributors, pharmacies, and directly to consumers via e-commerce and retail channels. This channel is particularly significant for over-the-counter products, such as COVID-19 home tests, enabling broader market access for individuals.
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Carrie Eglinton Manner, President and Chief Executive Officer
Carrie Eglinton Manner was appointed President and Chief Executive Officer of OraSure Technologies in June 2022, bringing over 25 years of healthcare leadership and transformation expertise. Prior to joining OraSure, she served as Senior Vice President, Advanced & General Diagnostics Clinical Solutions, at Quest Diagnostics, where she was responsible for launching innovative diagnostic solutions and led the molecular genetics team in pioneering next-generation sequencing innovation. Before her tenure at Quest Diagnostics, Ms. Eglinton Manner spent two decades at GE Healthcare, holding various leadership roles, including President and CEO of multiple distinct business units with global engineering and manufacturing responsibilities. She holds a B.S. degree in mechanical engineering from the University of Notre Dame.
Kenneth J. McGrath, Chief Financial Officer
Kenneth J. McGrath was named Chief Financial Officer in August 2022, overseeing finance, accounting, tax, and information technology for OraSure Technologies. Before joining OraSure, Mr. McGrath spent eight years at Quest Diagnostics, most recently as Vice President in Finance, where he led an organization managing over $7 billion in revenue and helped build Quest's Advanced Diagnostics business. His career also includes various finance leadership positions at Johnson & Johnson, Inc., and he began his professional journey as an engineer at Ford Motor Company. Mr. McGrath holds an M.B.A from the University of Michigan and a B.S. from the University of Notre Dame, and he is a CFA Charterholder.
Michele Anthony, Senior Vice President, Controller, and Chief Accounting Officer
Michele Anthony serves as Senior Vice President, Controller, and Chief Accounting Officer at OraSure Technologies.
Anne Messing, Chief Commercial Officer
Anne Messing is the Chief Commercial Officer at OraSure Technologies.
David Rappaport, CFA, Senior Vice President, Corporate Development, Strategy and Integration
David Rappaport is the Senior Vice President, Corporate Development, Strategy and Integration at OraSure Technologies. He is also a CFA Charterholder.
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The key risks to OraSure Technologies (OSUR) include the potential failure of a crucial new product launch, a trend of declining revenues across its core business segments coupled with ongoing cash burn, and significant uncertainties surrounding public health funding.
- Failure of the Sherlock CT/NG Testing Kit Launch: The successful launch and market adoption of the Sherlock CT/NG testing kit are considered the "single most important catalyst" for OraSure Technologies' turnaround, with its failure representing the "largest risk" to the company. The future of OraSure is heavily dependent on the success of this at-home STD test kit, including its FDA approval and market penetration.
- Declining Core Business Revenues and Cash Burn: OraSure Technologies has experienced a substantial decline in revenue across its Diagnostics and Sample Management Solutions segments following the COVID-19 pandemic. This decline is attributed to decreased international HIV revenues, reduced domestic orders, and the loss of a significant consumer genomics customer. As a result, the company is "burning cash" as it attempts to stabilize and grow its business.
- Uncertainty in Public Health Funding: OraSure Technologies faces ongoing challenges due to "elevated levels of uncertainty related to funding for public health programs and research as well as the government shutdown in the U.S." This funding instability is expected to contribute to a decline in both international and U.S. Diagnostics revenue for the company.
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OraSure Technologies (OSUR) operates in several distinct markets with varying addressable market sizes:
- HIV Self-Testing: The global HIV self-testing market was estimated at USD 211.55 million in 2024 and is projected to reach USD 643.41 million by 2033. North America held the largest revenue share of 33.40% in this market in 2024, with the U.S. being the leading country in the North American market.
- Microbiome Products and Services: The global microbiome market was expected to grow from approximately $325 million in 2017 to $725 million or more in 2022.
- Infectious Disease Diagnostics (Overall): The global infectious disease in-vitro diagnostics market size is estimated at USD 28.10 billion in 2025 and is forecasted to reach approximately USD 34.87 billion by 2034. The North American market for in-vitro diagnostics for infectious diseases surpassed USD 10.70 billion in 2024. Specifically, the U.S. infectious disease in-vitro diagnostics market was valued at USD 7.49 billion in 2024 and is projected to reach around USD 9.71 billion by 2034.
- Point-of-Care (POC) Diagnostics: The global point-of-care diagnostics market was valued at approximately $37.5 billion in 2023 and is projected to reach approximately $50 billion by 2028.
- Sexually Transmitted Infection (STI) Testing: OraSure's acquisition of Sherlock Biosciences targets the $1.5 billion STI testing market, specifically for rapid, at-home molecular diagnostics for Chlamydia and gonorrhea.
The company is also looking to expand into the blood proteomics market with new collection devices, which they describe as a "large and rapidly growing market," but a specific market size in USD was not identified in the provided information. For COVID-19 testing, OraSure's revenue from this area has seen a significant decline, projected to be under $100,000 for 2025, indicating a vastly reduced addressable market for their specific COVID-19 products. Information regarding the addressable market size for their drugs of abuse testing and cryosurgical products was not available.
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OraSure Technologies (OSUR) is expected to drive future revenue growth over the next 2-3 years through several key initiatives:
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New Product Launches and Strategic Acquisitions: OraSure is focused on new product developments expected in 2025 and 2026. The acquisition of Sherlock Biosciences is anticipated to expand its innovation pipeline with an advanced molecular diagnostics platform for rapid self-testing, initially targeting conditions such as chlamydia and gonorrhea (CTNG). Additionally, the acquisition of BioMedomics is set to enhance OraSure's diagnostic portfolio with the Sickle SCAN rapid test for sickle cell disease, leveraging existing international sales channels.
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Expansion and Diversification of Customer Base and Market Penetration: The company aims to strengthen existing customer relationships and establish new ones, thereby expanding the markets served by its rapid diagnostics. This includes driving multi-product sales across its portfolio of HIV, HCV, and Syphilis tests. Diversifying the customer base and product portfolio is a key part of the company's growth strategy.
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Sustained Performance and Recovery in International HIV Diagnostics: OraSure has experienced strong order trends in its international HIV business, contributing to year-over-year diagnostics revenue growth. Despite some anticipated moderation due to changes in national health program funding in 2025, the underlying demand and preference for their oral fluid testing internationally are expected to support continued revenue generation.
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Growth of Core Business Segments, including Sample Management Solutions: The company anticipates a return to year-over-year core revenue growth in the fourth quarter of 2024. While the sample management business has faced some headwinds, excluding specific customer impacts, this segment is positioned for positive year-over-year growth, indicating a gradual recovery in key end markets.
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Share Repurchases
- OraSure Technologies authorized a $40 million stock repurchase program in March 2025, to be funded from cash on hand over a 24-month period.
- The company deployed $5 million to repurchase approximately 1.5 million shares of its common stock in Q3 2025.
- An additional $5 million was deployed during Q2 2025 to repurchase 1.8 million shares of common stock.
Share Issuance
- On May 14, 2025, stockholders approved an amendment to the Stock Award Plan, increasing the shares authorized for issuance by 6,000,000.
Outbound Investments
- OraSure signed a definitive agreement to acquire BioMedomics, which will enhance its diagnostic portfolio with the Sickle SCAN test for sickle cell disease.
- The company deployed $5.0 million for the acquisition of Sherlock Biosciences during Q4 2024.
- OraSure made a $30.0 million investment in Sapphiros, as reported in the Form 10-K filing for the fiscal year ended December 31, 2024.
Capital Expenditures
- Capital expenditures in the last twelve months (as of November 5, 2025) totaled -$3.73 million.
- Projected capital expenditures are $12 million for 2025, $13 million for 2026, and $15 million for 2027.
- A primary focus of capital expenditures includes investments in the Sherlock platform, the CTNG clinical trial, and other innovation projects, with $10 million allocated for innovation investments in Q4 2025, including $7 million to $8 million for Sherlock-related developments.
