OraSure Submits Rapid Self-Test Applications for FDA Clearance
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
0mins
Should l Buy OSUR?
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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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 Q4 2025 Earnings Call Insights
- Financial Performance Overview: OraSure reported total revenue of $26.8 million in Q4 2025, with core revenue at $26.7 million, driven by $15.1 million from Diagnostic Products and $9.1 million from Sample Management Solutions, while gross margin improved to 41%, reflecting the company's efforts to stabilize revenue.
- Product Launch Plans: The company plans to launch two new products in mid-2026, including a rapid molecular self-test and an at-home urine collection device, marking significant milestones in its innovation roadmap and expected to drive future revenue growth.
- International Market Expansion: OraSure expanded its presence in Canada with the launch of the OraQuick HIV Self-Test and signed framework agreements with 14 African countries, highlighting the company's focus on global markets and their growth potential.
- Future Outlook: The CFO projected that new product launches in the second half of 2026 will drive revenue growth, and despite regulatory uncertainties, the company remains committed to achieving profitable growth through cost control and operational efficiency improvements.
See More
OraSure Technologies Schedules Q4 2025 Earnings Call for February 25, 2026
- Earnings Call Announcement: OraSure Technologies has scheduled its earnings conference call for Q4 2025 on February 25, 2026, at 5 PM ET, to report financial results and business developments to investors.
- Webcast Availability: The conference call will be available via webcast on OraSure's investor relations page, requiring investors to register and access the link at least 10 minutes prior to the call to ensure participation.
- Company Overview: OraSure Technologies focuses on transforming health through actionable insights and decentralizing diagnostics, enhancing healthcare access, quality, and value with innovative rapid tests and sample management solutions.
- Global Sales Network: OraSure's product portfolio, which includes rapid diagnostic tests and sample collection devices, is sold globally to clinical laboratories, hospitals, physician offices, and public health organizations, underscoring its leadership position in the global healthcare market.
See More
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.
See More
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.
See More
OraSure Submits FDA Applications for Rapid Self-Test Devices with $1.5B Market Potential
- Innovation Milestone: OraSure submitted FDA applications for rapid self-tests for Chlamydia trachomatis and Neisseria gonorrhoeae at the end of 2025, marking significant progress on its innovation roadmap and potentially enhancing its leadership in the rapid diagnostics market.
- Market Opportunity: The rapid 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 for CT/NG testing, indicating substantial market expansion potential for OraSure in the rapid testing sector.
- Enhanced Convenience: The new device utilizes a self-collected swab and allows results to be read directly without an electrical connection, which enhances user flexibility and convenience, aligning with patient preferences for private and convenient testing, thereby potentially increasing market acceptance.
- Collaborative Development: OraSure also submitted an application for the Colli-Pee™ at-home urine collection device, aimed at expanding access to testing and developed in collaboration with a leading diagnostics platform provider, further solidifying its leadership position in novel collection devices and chemistries.
See More
OraSure Submits Two FDA Applications, Addressable Market Exceeds $1.5 Billion
- 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.
See More
OraSure Technologies Q4 2025 Earnings Call Insights
- Financial Performance Overview: OraSure reported total revenue of $26.8 million in Q4 2025, with core revenue at $26.7 million, driven by $15.1 million from Diagnostic Products and $9.1 million from Sample Management Solutions, while gross margin improved to 41%, reflecting the company's efforts to stabilize revenue.
- Product Launch Plans: The company plans to launch two new products in mid-2026, including a rapid molecular self-test and an at-home urine collection device, marking significant milestones in its innovation roadmap and expected to drive future revenue growth.
- International Market Expansion: OraSure expanded its presence in Canada with the launch of the OraQuick HIV Self-Test and signed framework agreements with 14 African countries, highlighting the company's focus on global markets and their growth potential.
- Future Outlook: The CFO projected that new product launches in the second half of 2026 will drive revenue growth, and despite regulatory uncertainties, the company remains committed to achieving profitable growth through cost control and operational efficiency improvements.
See More
OraSure Technologies Schedules Q4 2025 Earnings Call for February 25, 2026
- Earnings Call Announcement: OraSure Technologies has scheduled its earnings conference call for Q4 2025 on February 25, 2026, at 5 PM ET, to report financial results and business developments to investors.
- Webcast Availability: The conference call will be available via webcast on OraSure's investor relations page, requiring investors to register and access the link at least 10 minutes prior to the call to ensure participation.
- Company Overview: OraSure Technologies focuses on transforming health through actionable insights and decentralizing diagnostics, enhancing healthcare access, quality, and value with innovative rapid tests and sample management solutions.
- Global Sales Network: OraSure's product portfolio, which includes rapid diagnostic tests and sample collection devices, is sold globally to clinical laboratories, hospitals, physician offices, and public health organizations, underscoring its leadership position in the global healthcare market.
See More
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.
See More
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.
See More
OraSure Submits FDA Applications for Rapid Self-Test Devices with $1.5B Market Potential
- Innovation Milestone: OraSure submitted FDA applications for rapid self-tests for Chlamydia trachomatis and Neisseria gonorrhoeae at the end of 2025, marking significant progress on its innovation roadmap and potentially enhancing its leadership in the rapid diagnostics market.
- Market Opportunity: The rapid 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 for CT/NG testing, indicating substantial market expansion potential for OraSure in the rapid testing sector.
- Enhanced Convenience: The new device utilizes a self-collected swab and allows results to be read directly without an electrical connection, which enhances user flexibility and convenience, aligning with patient preferences for private and convenient testing, thereby potentially increasing market acceptance.
- Collaborative Development: OraSure also submitted an application for the Colli-Pee™ at-home urine collection device, aimed at expanding access to testing and developed in collaboration with a leading diagnostics platform provider, further solidifying its leadership position in novel collection devices and chemistries.
See More
OraSure Submits Two FDA Applications, Addressable Market Exceeds $1.5 Billion
- 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.
See More
