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OraSure Technologies Inc. develops, manufactures and distributes point-of-need and home diagnostic tests, along with sample collection and stabilization products used in healthcare and research settings. Its portfolio includes rapid diagnostic tests and sample management solutions sold to clinical laboratories, hospitals, physicians' offices, clinics, public health and community organizations, research institutions, government agencies, pharmaceutical companies and consumers.
OraSure news commonly covers quarterly results, manufacturing efficiency, product regulatory updates, commercial launches, research and development priorities, and capital allocation. Company updates also address subsidiaries including DNA Genotek, Sherlock Biosciences and BioMedomics, products such as OraQuick HIV self-testing and Colli-Pee urine collection, and governance matters involving board composition and shareholder engagement.
OraSure Technologies (NASDAQ: OSUR) received U.S. FDA Emergency Use Authorization on July 21, 2026 for its second-generation OraQuick™ Ebola 2.0 Rapid Antigen Test. The test is authorized for use with whole blood from live patients and cadaveric oral fluid from individuals suspected to have had Ebola disease at death.
The assay detects all four Ebola viruses known to cause human disease (Bundibugyo, Zaire, Sudan, Taï Forest), offers increased sensitivity with new chemistry and more automated manufacturing, and delivers qualitative results in 30 minutes without instruments or lab analysis. It was developed in cooperation with BARDA under Contract No. 75A50122C00079.
OraSure Technologies (NASDAQ:OSUR) received FDA clearance for its Colli-Pee™•Dx Urine Collection Kit, used with Roche cobas® 5800, 6800, and 8800 systems to test for CT, NG, TV, and MG.
The kit enables at-home, first-void urine self-collection at ambient temperatures, supporting scalable, mail-in, decentralized STI testing for broader patient access.
OraSure (NASDAQ: OSUR) reported Q1 2026 results: total net revenues $27.9M (down 7% year-over-year) and core revenues $27.9M (down 0.5%). GAAP gross margin was 42.3%; GAAP operating loss was $23.3M and net loss was $22.4M (diluted EPS $(0.32)).
Cash and cash equivalents were $177M at March 31, 2026; the company repurchased $5M of stock and guided Q2 2026 revenue of $27M–$30M.
OraSure (NASDAQ: OSUR) will report first quarter 2026 financial results and host a conference call at 5:00 p.m. ET on May 6, 2026. A live webcast will be available on the company investor relations website and will be archived shortly after the call.
Participants should register and join at least 10 minutes before the scheduled start.
OraSure Technologies (NASDAQ: OSUR) appointed John D. Bertrand to its board as an independent director, effective immediately, and announced a proposal to declassify the Board for shareholder vote at the 2026 Annual Meeting.
The company entered a Cooperation Agreement with Altai Capital under which Altai withdrew director nominations and will engage regularly with OraSure management; the agreement includes customary standstill and voting provisions and will be filed on Form 8-K.
OraSure (NASDAQ: OSUR) said it is progressing a transformation strategy and highlighted regulatory, commercial, operational, and capital-allocation milestones expected in 2026. Key facts include two FDA product submissions for a rapid molecular CT/NG self-test and Colli-Pee, a $40 million share repurchase program, and cost cuts that reduced SG&A by 37% since 2022.
The company said it has cut global staff ~40%, consolidated manufacturing in Pennsylvania, achieved ~260 bps adjusted gross margin expansion, and expects revenue growth in 2026 as product launches scale. OraSure rejected Altai demands to seat its founder and described ongoing proxy-related engagement.
OraSure Technologies (NASDAQ: OSUR) is the target of an activist campaign by Altai Capital Management, which holds about 5% of shares and has nominated two directors, Rishi Bajaj and John Bertrand.
Altai cites chronic underperformance, cash burn on speculative diagnostics, low director ownership, CEO pay misalignment, and urges a strategic review including a potential sale.
OraSure Technologies (NASDAQ: OSUR) reported Q4 2025 revenue of $26.8 million, above midpoint guidance, and total 2025 revenue of $115.0 million (down 38% YoY). GAAP gross margin improved to 41.0%. Q4 GAAP operating loss was $20.1 million and diluted EPS was $(0.27). Cash and cash equivalents were $199.3 million at Dec 31, 2025. The company submitted FDA applications in Dec 2025 for a rapid CT/NG molecular self-test and the Colli-Pee at-home urine collection device and received Health Canada authorization for the OraQuick HIV Self-Test. Q1 2026 revenue guidance: $26–29 million.
OraSure (NASDAQ: OSUR) received a Health Canada license for the OraQuick HIV Self-Test, Canada’s first oral HIV self-test, on Feb 10, 2026. The rapid antibody oral test detects HIV-1 and HIV-2 and delivers results in as little as 20 minutes.
St. Michael’s Hospital (Unity Health Toronto) will serve as exclusive Canadian distributor to provide national access; the test has been available direct-to-consumer in the U.S. since 2012 and is sold in 60+ countries.
OraSure (NASDAQ: OSUR) will report fourth quarter 2025 financial results and host an earnings conference call on February 25, 2026 at 5:00 PM ET. A live webcast will be available via the company's investor relations page and will be archived after the call.
Investors are asked to register and access the webcast at least 10 minutes before the start time.