OraSure Announces Fourth Quarter 2025 Financial Results

Revenue of $26.8 million was above the midpoint of guidance range, company expects return to growth in 2026

Published on Feb. 26, 2026

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OraSure Technologies, Inc., a leader in point-of-need and home diagnostic tests and sample management solutions, announced its financial results for the fourth quarter of 2025. The company reported revenue of $26.8 million, which was above the midpoint of its guidance range, but a 29% decrease from the prior year quarter. OraSure is confident it is positioned to return to growth in 2026 supported by anticipated U.S. regulatory clearance and launches of new rapid molecular self-tests and at-home urine collection devices.

Why it matters

OraSure's results reflect the challenges the diagnostics industry faced in 2025 with a difficult funding environment, but the company is encouraged by signs of stabilization in key segments as it enters 2026. The anticipated launches of new rapid molecular self-tests and at-home collection devices are expected to help drive OraSure's return to growth and strengthen its leadership position in decentralized diagnostics.

The details

OraSure reported total net revenues of $26.8 million for the fourth quarter of 2025, a 29% decrease from the prior year quarter. Core revenues, excluding COVID-19, Molecular Services, and Risk Assessment Testing, were $26.7 million, a 22% year-over-year decline. Diagnostics revenues decreased 20% to $15.1 million, while Sample Management Solutions revenues fell 39% to $9.1 million. GAAP gross margin was 41.0% in Q4 2025 compared to 36.2% in the prior year quarter. The company reported a GAAP operating loss of $20.1 million and a non-GAAP operating loss of $15.2 million in the quarter.

  • OraSure submitted an application in December 2025 to the FDA for clearance of its rapid molecular self-test for Chlamydia and Gonorrhea.
  • OraSure also submitted an application in December 2025 to the FDA for clearance of its Colli-Pee at-home urine collection device for sexually transmitted infections.
  • OraSure received a license from Health Canada in 2025 authorizing the use of the OraQuick HIV Self-Test in Canada.

The players

OraSure Technologies, Inc.

An American diagnostics company that is a leader in point-of-need and home diagnostic tests and sample management solutions.

Carrie Eglinton Manner

The President and CEO of OraSure Technologies.

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What they’re saying

“Our Q4 results were consistent with our expectations, and revenue of $26.8 million was above the midpoint of our guidance range.”

— Carrie Eglinton Manner, President and CEO of OraSure Technologies

“We are confident that OTI is positioned to return to growth in 2026, supported by anticipated U.S. regulatory clearance and launches of our rapid molecular self-test for Chlamydia and Gonorrhoeae and our Colli-Pee™ at-home urine collection device for sexually transmitted infections.”

— Carrie Eglinton Manner, President and CEO of OraSure Technologies

What’s next

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The takeaway

OraSure's results highlight the challenges the diagnostics industry faced in 2025, but the company's pipeline of new rapid molecular self-tests and at-home collection devices positions it to return to growth in 2026 and strengthen its leadership in decentralized diagnostics.