OraSure Submits Rapid Self-Test Applications for FDA Clearance
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.
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OraSure Technologies Nominates Board Candidates Amid Ongoing Refreshment Efforts
- Board Nominations: Altai Capital has nominated two candidates, including founder Rishi Bajaj, for election to OraSure's Board, indicating investor interest in corporate governance that may influence shareholder perceptions of the company's future direction.
- Board Refreshment: Since 2022, OraSure's Board has seen the departure of seven directors and the addition of three independent directors, including healthcare investor Steven K. Boyd in October 2025, aimed at enhancing industry perspectives and oversight capabilities.
- Shareholder Meeting Plans: OraSure will review Altai's nominations at its 2026 Annual Meeting and provide recommendations in a proxy statement to be filed with the SEC, ensuring shareholders have comprehensive information and choices during the election process.
- Advisory Support: With Evercore as financial advisor, Goodwin Procter LLP as legal counsel, and Joele Frank as strategic communications advisor, OraSure is bolstering its governance and shareholder communication efforts, enhancing transparency and trust among investors.
Altai Capital Nominates Two Directors to OraSure's Board, Stock Rises 1.7%
- Board Nominations: Altai Capital has nominated Digital Diagnostics CEO John Bertrand and Altai President Rishi Bajaj to OraSure's board, indicating a proactive approach to governance aimed at improving the company's stock performance.
- Shareholder Concerns: Holding a 5.2% stake in OraSure, Altai Capital previously sent a letter to the board expressing concerns about the company's 'significant share price underperformance,' urging the board to consider alternative strategies to enhance shareholder value.
- Stock Price Reaction: Following the nomination announcement, OraSure's stock rose by 1.7%, reflecting market optimism regarding the potential positive changes that the new board candidates may bring, thereby boosting investor confidence in the company's future.
- Growth Outlook: OraSure is signaling a return to growth in 2026 while expanding its diagnostics portfolio through the acquisition of BioMedomics, indicating that the company is taking steps to address market challenges and enhance its competitive position.
