Feb. 26, 2026

— Jeff Ward, Lehigh Valley News Briefs

Shares of Orasure rose today, after the Bethlehem-based maker of diagnostic kits reported fourth-quarter earnings Wednesday.

At the close of regular trading, the shares (NASDAQ:OSUR) were at $3.08, up 28 cents from the end of regular trading Wednesday. The stock has been a laggard for years, ever since the COVID-19 pandemic.

As usual, the numbers were not real great, but investors found something to like. Fourth-quarter 2025 revenue was $26.8 million, down 29% from $37.4 million in the year-ago quarter.

The company lost $19.3 million in the quarter. After adjustments, the fourth-quarter loss was $13.6 million, or 19 cents per share.

Revenue fell and OraSure lost money. Still, the company has $199 million in cash as of Dec. 31, 2025 and no debt.

Perhaps Chief Executive Carrie Eglinton Manner’s comments on sexually transmitted infections spurred investor interest: “We are confident that (OraSure) 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.”

During the company’s conference call, Eglinton Manner discussed prospects in Africa and Canada. She discussed her vision for the company’s goal of home testing.

This being OraSure, jargon is inevitable. The “innovation road map,” the “strategic transformation,” “incentivize” and “near-shoring,” which means moving activities closer to certain users in Africa.

Eglinton Manner said 2025 was a “transition year.” The stock started the year at $3.61 and finished at $2.42. It lost about a third of its value over 2025. That is a transition, but not one I’d be bragging about.

Perhaps the new products will bring in some revenue. The company needs something. It’s been staggering since the pandemic bought in millions of government dollars. Future COVID revenue is deemed to be negligible. The company also cut some non-production jobs in 2025.

Here’s an abbreviated version of yesterday’s report, and here is a link to the entire statement:

Press Release

OraSure Announces Fourth Quarter 2025 Financial Results

February 25, 2026 at 4:05 PM EST

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BETHLEHEM, Pa., Feb. 25, 2026 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended December 31, 2025.

“Our Q4 results were consistent with our expectations, and revenue of $26.8 million was above the midpoint of our guidance range,” said Carrie Eglinton Manner, President and CEO of OTI. “We supported our customers in navigating a challenging funding environment in 2025, and we are encouraged to see increasing signs of stability in key segments as we enter 2026.”

She continued, “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. We are making meaningful progress on our innovation roadmap and executing on our strategy to decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private. Additionally, our strong balance sheet allows us to make disciplined investments in value-enhancing organic and inorganic opportunities while prudently returning capital to shareholders through our $40 million share repurchase program which we continue to execute.”

— TABLES OMITTED —

• Total net revenues for the fourth quarter of 2025 decreased 29% to $26.8 million from $37.4 million in the fourth quarter of 2024.
• Core revenues (all revenues excluding COVID-19, Molecular Services, and Risk Assessment Testing revenues) of $26.7 million in the fourth quarter decreased 22% year-over-year. Diagnostics revenues in the fourth quarter decreased 20% year-over-year to $15.1 million, with the decline attributable to lower revenue from our HIV tests. Sample Management Solutions revenues in the fourth quarter decreased 39% year-over-year to $9.1 million, with the majority of the decline attributable to a large customer in the consumer genomics segment.
• GAAP gross margin was 41.0% in the fourth quarter of 2025 compared to 36.2% in the fourth quarter of 2024. Non-GAAP gross margin in the fourth quarter of 2025 was 41.4% compared to 40.1% in the fourth quarter of 2024¹.
• GAAP operating loss in the fourth quarter of 2025 was $20.1 million compared to operating loss of $12.4 million in the fourth quarter of 2024. Non-GAAP operating loss was $15.2 million in the fourth quarter of 2025 compared to non-GAAP operating loss of $6.7 million in the fourth quarter of 2024.
• Cash and cash equivalents were $199 million as of December 31, 2025.
• OTI deployed $5 million during the fourth quarter to repurchase approximately 1.9 million shares of our common stock.

¹ For additional information on non-GAAP financial measures and a reconciliation of the GAAP financial results to non-GAAP financial results, see the schedules below. A description of the adjustments made to the GAAP financial measures is included at the end of the schedules.

Recent Business Developments

• Submitted an application in December 2025 to the U.S. Food and Drug Administration (FDA) for clearance of our rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). OTI’s rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. The test uses a self-collected swab, and results are intended to be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience.
• Submitted an application in December 2025 to the FDA for clearance of our Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs). The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. Receipt of clearance for the Colli-Pee™ device for these indications is expected to expand access to testing and further strengthen OTI’s leadership position in novel collection devices and chemistries.
• Received a license from Health Canada authorizing the use of the OraQuick™ HIV Self-Test in Canada. St. Michael’s Hospital (Unity Health Toronto) is the exclusive distributor in Canada of the OraQuick HIV Self-Test, which is the country’s first oral HIV self-test.
  

Financial Guidance

The Company is guiding to Q1 2026 Total revenues of $26 million to $29 million, which includes a negligible amount of COVID-19 testing revenues.