OraSure Technologies, Inc
OraSure Technologies is a U.S.-based diagnostics and specimen-collection company that develops, manufactures, markets, and sells rapid tests and related collection devices. Its portfolio includes oral-fluid and other in vitro diagnostic tests, HIV and hepatitis self-tests, and sample management products used across clinical, public health, research, and commercial settings.
Fiscal year 2025 · change from previous year
Development 2020–2025
Business
Share of revenueRapid diagnostic tests sold to healthcare and public health customers for infectious disease screening.
At-home and self-administered infectious disease tests sold through retail and distribution channels.
Specimen collection and sample handling products for clinical, research, and commercial labs.
Smaller product lines and service revenues, including research-use devices and related services.
Products
Reported · share of revenue- Product and Services94.8 %
- Other Revenues5.2 %
Source: 10-K FY2025, revenue the company reports per product line (SEC XBRL). Shares are of the lines shown and add up to 100 %.
Customers
OraSure sells to a mix of public health agencies, hospitals, physician offices, clinics, distributors, and retail channels, with additional demand from laboratories and research-oriented commercial customers. Its diagnostics are used for infectious disease screening and self-testing, while sample management products are bought by clinical labs, direct-to-consumer testing providers, pharmaceutical and biotech customers, and academic or research users.
Buy HIV, HCV, and other infectious disease tests for screening and outreach programs.
Buy rapid diagnostic tests for point-of-care infectious disease testing.
Buy self-test products and resell them into consumer and institutional markets.
Buy sample collection and management products for testing workflows.
Buy specimen collection devices and related products for studies and assay development.
Buy sample management products for veterinary and animal-health applications.
Strategy
OraSure’s strategy centers on expanding simple, easy-to-use diagnostics and specimen-collection products across professional, public health, self-test, and research channels. The company also emphasizes proprietary technologies, regulatory clearances, and distribution partnerships to support commercialization and broaden access to its products.
These products fit the company's ease-of-use positioning and broaden end-market reach.
FDA and other approvals are required to commercialize new diagnostic offerings.
Distribution access is critical in fragmented diagnostics markets and international sales.
These products diversify the portfolio beyond infectious disease testing.
Geography
Q1/2026OraSure markets products in the United States and internationally, with U.S. public health and clinical customers representing a core market. International demand is important for HIV-related products, and the company also uses distributors in certain foreign countries for selected tests and sample management products.
Share of the revenue the company reports by geography.
Risks
OraSure faces regulatory, reimbursement, and competitive risks typical of diagnostics companies, along with customer concentration and dependence on government-funded purchasing. Its results also depend on manufacturing quality, distributor execution, intellectual property protection, and continued acceptance of oral-fluid and self-testing products.
- Government funding and ordering riskImpact: HighLikelihood: High
A meaningful portion of demand depends on public programs and grant-funded customers.
Exposure: HIV and public health testing markets
- Regulatory approval and compliance riskImpact: HighLikelihood: Medium
New diagnostics require FDA or other clearances, and noncompliance can halt sales or trigger recalls.
Exposure: New products and existing regulated tests
- Manufacturing and quality riskImpact: HighLikelihood: Medium
Products must meet performance and regulatory standards to remain sellable.
Exposure: All diagnostic and collection products
- Distributor dependenceImpact: MediumLikelihood: Medium
Third-party distributors control sales execution in several markets and geographies.
Exposure: International and retail channels
- Competition in diagnosticsImpact: MediumLikelihood: Medium
Larger competitors have greater resources and can pressure pricing and market share.
Exposure: Rapid tests and sample collection products
- Customer concentrationImpact: MediumLikelihood: Low
A small number of customers can represent a disproportionate share of revenue.
Exposure: Large distributors and institutional buyers
Accounting
Judgemental itemsRevenue is booked when control transfers, so shipment timing and channel inventory matter.
Impact: Quarterly revenue comparability
Retail self-tests and certain products have return rights and warranty exposure.
Impact: Net revenue and gross margin
Acquired assets are tested for impairment and can create non-cash charges.
Impact: Earnings and balance sheet carrying values
Acquisition-related liabilities are remeasured and can create income statement volatility.
Impact: Operating results
Discounts, rebates, and allowances reduce recognized revenue.
Impact: Reported net sales
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Last updated: 24/09/2026