OSUR News & Events

OraSure Technologies announced its OraQuick HIV Self-Test has received a license from Health Canada for use in Canada. The OraQuick HIV Self-Test is a point-of-care rapid antibody test. It is Canada's first oral HIV self-test and detects antibodies for both HIV-1 and HIV-2.

OraSure Technologies confirmed that Altai Capital has nominated two candidates, including the fund's founder Rishi Bajaj, to stand for election to the company's board at its 2026 Annual Meeting of Stockholders, stating: "As previously announced, OraSure's Board has engaged extensively with Altai Capital. The Board interviewed Mr. Bajaj for potential service on the Board and ultimately decided to appoint an alternative candidate to serve as a director at OraSure. Since that time, Altai has not accepted the Board's offers to make certain of its directors available to engage further. OraSure maintains a strong, independent, and engaged Board. We continually assess our Board composition, and as a result our Board has undergone significant refreshment, bringing in industry perspectives and executive-level experience to provide oversight as management drives growth and value creation... The Nominating and Corporate Governance Committee and OraSure's Board will review Altai's nominations, and the Board will present its recommendation in the Company's definitive proxy statement to be filed with the Securities and Exchange Commission and mailed to stockholders eligible to vote at the Company's 2026 Annual Meeting of Stockholders, which has not yet been scheduled. OraSure shareholders are not required to take any action at this time."

Altai Capital Management, one of the largest shareholders and beneficial owners of approximately 5.2% of the outstanding common stock of OraSure Technologies, announced that it has nominated two candidates, John Bertrand, co-founder of Digital Diagnostics, and Rishi Bajaj, president and CIO of Altai, for election to the OraSure board of directors at the 2026 annual meeting of stockholders.

OraSure Technologies submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae as well as its Colli-Pee at-home urine collection device for sexually transmitted infections. 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 can be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience. OTI estimates that testing for CT/NG represents a total addressable market of more than $1.5B. Today, the vast majority of CT/NG tests in the U.S. are processed in centralized laboratories, creating an opportunity for meaningful market expansion through the introduction of an affordable rapid self-test. OTI also submitted the Colli-Pee device, which is designed for at-home urine collection and is aligned with patient preferences for private and convenient diagnostic testing. 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 would be in addition to the existing Research-use Only product and is expected to expand access to testing and further strengthen OTI's leadership position in novel collection devices and chemistries.