OraSure Submits Two FDA Applications, Addressable Market Exceeds $1.5 Billion
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Source: Newsfilter
- Innovation Milestone: OraSure submitted applications to the FDA for its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae at the end of 2025, marking significant progress in decentralizing diagnostics and enhancing market competitiveness.
- Market Opportunity: OTI's CT/NG self-test, built on the Sherlock molecular diagnostics platform, is designed to deliver results in approximately 30 minutes, targeting a total addressable market exceeding $1.5 billion, which could significantly expand the current centralized laboratory testing market.
- Enhanced Convenience: The submission of the Colli-Pee™ at-home urine collection device aims to meet patient preferences for private and convenient testing, expected to further strengthen OTI's leadership position in novel collection devices.
- Strategic Execution: OraSure's CEO emphasized that the company will continue to drive its innovation strategy in 2026, aiming to create value for all stakeholders, reflecting a proactive positioning in the rapidly evolving healthcare market.
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About OSUR
OraSure Technologies, Inc. transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. The Company improves the access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. The Company, together with its wholly owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., is engaged in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. Its portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct consumers. Its products and services include OraQuick ADVANCE Rapid HIV1/2 Antibody Test, OraQuick HIV Self-Test, and Diagnostics Direct Syphilis Health Check.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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.
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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.
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