OraSure Technologies (NASDAQ:OSUR) reported fourth-quarter 2025 revenue of $26.8 million, with management pointing to early signs of stabilization across key end markets after what it described as a transition year marked by a challenging funding environment. On the company’s earnings call, executives also highlighted two mid-year product launches as near-term growth catalysts, following FDA submissions made in December.
Fourth-quarter results and segment performance
Chief Financial Officer Ken McGrath said core revenue—excluding COVID-19 products—was $26.7 million, which management noted was above the midpoint of the company’s guidance range. Diagnostic products generated $15.1 million in fourth-quarter revenue, while sample management solutions contributed $9.1 million, both described as consistent with expectations.
Funding dynamics and international diagnostics updates
President and CEO Carrie Eglinton Manner said 2025 was a transition year in which OraSure supported customers “in navigating a challenging and uncertain funding environment.” Entering 2026, she said the company is seeing “increasing signs of stability in key segments,” including improved visibility to funding for testing and research programs.
In international diagnostics, management said order trends are stabilizing as national health programs adapt to revised funding structures. Manner pointed to framework agreements signed between the U.S. and more than 12 countries in Africa that incentivize greater local investment. She said OraSure is working more closely with distribution partners in Africa on in-country value-added assembly and manufacturing, describing this as “nearshoring,” and expects expanded local relationships to begin contributing revenue in the first quarter and throughout 2026.
During Q&A, management discussed the disruption in international HIV ordering cadence in 2025 tied to PEPFAR and USAID implementation issues. Executives said they are seeing improved visibility as countries in Africa work through funding and program implementation, with increased local investment under bilateral agreements. McGrath added that the nearshoring model could become a meaningful incremental revenue opportunity over time.
OraSure also highlighted expansion in Canada following a license from Health Canada for the OraQuick HIV Self-Test. Management said the product is Canada’s first oral HIV self-test and that the company will work with St. Michael’s Hospital, Unity Health Toronto, as the exclusive distributor.
On the BioMedomics acquisition, which closed in November, Manner said integration is “off to a good start.” She cited strong demand for the Sickle SCAN test, a rapid point-of-need test for sickle cell disease, and said OraSure is seeking to expand adoption through its international sales channels and relationships with national health programs, particularly in Africa and Latin America.
Sample management outlook and market stabilization
In sample management, Manner said OraSure remains confident the business is positioned to deliver growth in 2026 and beyond as genomic end markets stabilize and gradually return to stronger growth, driven by clinical adoption of precision medicine. She also cited anticipated modest contributions to growth from academic and government segments, international markets, and progress with a blood proteomic solution launched in mid-2025.
In response to an analyst question, McGrath said that when excluding one large customer headwind referenced by the company previously, sample management showed year-over-year growth for the full year 2025. He attributed that to a combination of market factors and diversification of the customer base.
Pipeline and product launch plans
Management emphasized two planned launches around midyear 2026 and said revenue is expected to ramp in the second half of the year. In late December, the company submitted to the FDA its rapid molecular self-test for chlamydia and gonorrhea (CT/NG), built on the Sherlock molecular diagnostics platform. Manner said the test is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format, using a self-selected swab and a handheld device that does not require an electrical connection. OraSure estimates CT/NG testing represents a total addressable market of more than $1.5 billion, and management said a rapid self-test could expand the market given that most tests are currently processed in centralized labs.
Also in December, OraSure submitted a separate FDA application for clearance of its Colli-Pee at-home urine collection device for STI indications, including proprietary stabilization chemistry. Manner said the submission covers multiple STI indications and is being pursued in collaboration with a “leading diagnostics platform provider.” She added that clearance would be in addition to the research-use-only product and is expected to expand access to testing while strengthening OraSure’s position in collection devices and chemistries.
Asked about FDA timing and the second-half revenue ramp, management reiterated it is working toward a mid-year launch but said regulatory review timing carries uncertainty and that providing more precise timing would be “false precision.”
Capital position, cash flow, and first-quarter guidance
OraSure ended 2025 with zero debt and $199 million in cash and cash equivalents. McGrath said the company repurchased $5 million of stock in the fourth quarter, representing 1.9 million shares. For the full year, OraSure returned $15 million to shareholders through repurchases totaling 5.3 million shares. He said the company continues to evaluate organic and inorganic growth opportunities and referenced the approximately $4 million investment in the BioMedomics acquisition during the quarter.
Operating cash flow in the fourth quarter was negative $9 million, which management attributed to investments in the Sherlock platform, clinical trials for the CT/NG test and Colli-Pee, and other innovation projects. McGrath said OraSure expects to return to breakeven operating cash flow as it enters 2027, driven by an expected return to revenue growth, anticipated contributions from product launches, and continued cost savings from operating efficiencies.
For the first quarter, OraSure guided revenue to a range of $26 million to $29 million, including a negligible amount of COVID-19 testing revenue. The company expects first-quarter gross margin to be in the low 40% range, with slight sequential improvement versus the fourth quarter. McGrath also discussed manufacturing consolidation efforts, including moving some HIV testing production to the Bethlehem facility and internalizing much of sample management volume previously handled by contractors in Canada, noting that margin benefits are expected as volume ramps and transition costs subside.
On the expense side, management said it recently eliminated a number of non-production roles and is taking actions to increase operating efficiencies, partially offset by targeted commercial investments to support upcoming launches and one-time severance and non-recurring costs. In Q&A, the company also said it expects lower R&D expense over the full year 2026 compared with 2025 as clinical trial spending tapers, though some work will continue in the first quarter to support performance claims ahead of launches.
About OraSure Technologies (NASDAQ:OSUR)
OraSure Technologies, Inc is a Bethlehem, Pennsylvania–based diagnostic and medical device company specializing in the development, manufacture and commercialization of point-of-care and self-testing products. Founded in 1988, OraSure has built a portfolio of oral fluid and other non-invasive specimen collection technologies that support the detection of infectious diseases, drugs of abuse, and health and wellness biomarkers.
The company’s flagship product, the OraQuick® rapid HIV test, was the first Food and Drug Administration–approved over-the-counter oral fluid test for the detection of HIV-1/2 antibodies.
