OraSure Receives FDA Clearance for Colli-Pee Dx Urine Collection Kit
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 11 2026
0mins
OraSure (OSUR) announced FDA clearance of its Colli-Pee Dx Urine Collection Kit from its subsidiary DNA Genotek Inc., for use with Roche's (RHHBY) tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium and run on Roche's cobas 5800, 6800, and 8800 molecular diagnostic systems. The FDA-cleared collection kit supports at-home self-collection of first-void urine, enabling convenient sample collection at-home or in any private setting for both male and female patients.
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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, 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 products and services include OraQuick ADVANCE Rapid HIV 1/2 Antibody Test, OraQuick HIV Self-Test, Diagnostics Direct Syphilis Health Check, OraQuick Ebola Rapid Antigen Test, InteliSwab COVID-19 Rapid Test Pro, and SickleSCAN Test, among others. 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.
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 Receives FDA Clearance for Urine Collection Kit
- FDA Approval Milestone: OraSure's Colli-Pee™•Dx Urine Collection Kit has received FDA clearance for use with Roche's molecular diagnostic systems, marking a significant advancement in patient-centric diagnostics and expected to enhance the company's competitiveness in the home testing market.
- Convenient Self-Collection: The kit enables both male and female patients to self-collect urine in home or private settings, utilizing NucleoPrecision™ technology to ensure sample stability at ambient temperatures, thereby improving reliability and convenience for STI testing and addressing the demand for non-invasive collection methods.
- Expanded Testing Access: With a streamlined mail-in workflow, laboratories and health systems can efficiently process self-collected urine specimens, improving service to underserved populations and supporting public health initiatives focused on early detection and treatment of STIs, which has significant social implications.
- Strategic Innovation Commitment: OraSure's CEO Carrie Eglinton Manner emphasized that this clearance showcases the potential of designing solutions around patient behavior, reflecting meaningful progress on the company's innovation roadmap and commitment to providing user-friendly testing devices in decentralized settings.
See More
OraSure Technologies Q1 2026 Earnings Call Insights
- Revenue Growth: OraSure reported total revenue of $27.9 million in Q1 2026, exceeding the midpoint of its guidance range and growing 4% sequentially, indicating steady progress in its strategic transformation and laying a foundation for future growth.
- Product Launch Plans: The company is set to launch two new products mid-year, including a rapid molecular self-test device and an at-home urine collection device, which not only diversifies its product line but is also expected to significantly boost revenue in the second half of the year, enhancing market competitiveness.
- International Market Expansion: In its International Diagnostics business, OraSure has established closer relationships with distribution partners in Africa and has delivered initial orders to one near-shoring partner, indicating accelerated global market positioning and operational capabilities.
- Financial Health: As of the end of Q1, OraSure had zero debt and cash and cash equivalents of $177 million; despite a negative operating cash flow of $14 million, the company anticipates returning to breakeven in operating cash flow by 2027, demonstrating strong financial management.
See More
OraSure (OSUR) Q1 2026 Earnings Transcript
See More
Surge in Options Trading Volume for OraSure and CleanSpark
- OraSure Options Volume: OraSure Technologies Inc. saw options trading volume of 2,076 contracts, equating to approximately 207,600 shares, which represents about 64.5% of its average daily trading volume of 321,695 shares over the past month, indicating strong market interest in its future performance.
- High Strike Demand: Notably, the $2.50 strike call option expiring on July 17, 2026, has seen 2,065 contracts traded today, representing around 206,500 shares, suggesting a bullish sentiment among investors regarding this price point.
- CleanSpark Options Volume: CleanSpark Inc. recorded an options trading volume of 119,991 contracts, translating to approximately 12.0 million shares, which accounts for 60.9% of its average daily trading volume of 19.7 million shares over the past month, reflecting significant market attention on its stock.
- Significant Strike Activity: The $16 strike call option expiring on June 18, 2026, has seen 14,108 contracts traded today, representing about 1.4 million shares, indicating investor confidence in CleanSpark's future growth potential.
See More
OraSure Technologies Schedules Q1 2026 Earnings Call for May 6
- Earnings Call Announcement: OraSure Technologies has scheduled its earnings conference call for Q1 2026 on May 6 at 5 PM ET, highlighting the company's commitment to transparency and investor communication regarding financial results and business developments.
- Webcast Availability: The conference call will be available via webcast on OraSure's investor relations page, requiring investors to register at least 10 minutes prior to the call, which enhances timely information dissemination and investor engagement.
- Company Overview: OraSure focuses on transforming health through actionable insights and decentralized diagnostics, providing innovative testing and sample management solutions that improve healthcare access and quality, underscoring its leadership in rapid diagnostic testing.
- Global Sales Network: OraSure's product portfolio is sold globally to various channels, including clinical laboratories and hospitals, indicating its extensive influence and market penetration within the healthcare industry.
See More
OraSure Partners with Altai Capital, Appoints John D. Bertrand to Board
- Board Transformation: OraSure has entered into a cooperation agreement with activist investor Altai Capital, appointing John D. Bertrand to the board, aiming to enhance governance through regular discussions on financial and strategic matters, thereby boosting investor confidence.
- Shareholder Voting Plan: The company plans to seek shareholder approval to declassify its board at the 2026 annual meeting, a move that will improve board transparency and accountability, potentially attracting more investor interest.
- Activist Investor Impact: Following the agreement, Altai Capital withdrew its director nominations, indicating an improving relationship with OraSure that could facilitate sustainable value growth for the company in the future.
- Potential Acquisition Call: Altai reiterated its call for a potential sale of OraSure last month, suggesting that such a move could potentially double the medical device maker's share price, further driving the company's strategic transformation and market performance.
See More
OraSure Receives FDA Clearance for Urine Collection Kit
- FDA Approval Milestone: OraSure's Colli-Pee™•Dx Urine Collection Kit has received FDA clearance for use with Roche's molecular diagnostic systems, marking a significant advancement in patient-centric diagnostics and expected to enhance the company's competitiveness in the home testing market.
- Convenient Self-Collection: The kit enables both male and female patients to self-collect urine in home or private settings, utilizing NucleoPrecision™ technology to ensure sample stability at ambient temperatures, thereby improving reliability and convenience for STI testing and addressing the demand for non-invasive collection methods.
- Expanded Testing Access: With a streamlined mail-in workflow, laboratories and health systems can efficiently process self-collected urine specimens, improving service to underserved populations and supporting public health initiatives focused on early detection and treatment of STIs, which has significant social implications.
- Strategic Innovation Commitment: OraSure's CEO Carrie Eglinton Manner emphasized that this clearance showcases the potential of designing solutions around patient behavior, reflecting meaningful progress on the company's innovation roadmap and commitment to providing user-friendly testing devices in decentralized settings.
See More
OraSure Technologies Q1 2026 Earnings Call Insights
- Revenue Growth: OraSure reported total revenue of $27.9 million in Q1 2026, exceeding the midpoint of its guidance range and growing 4% sequentially, indicating steady progress in its strategic transformation and laying a foundation for future growth.
- Product Launch Plans: The company is set to launch two new products mid-year, including a rapid molecular self-test device and an at-home urine collection device, which not only diversifies its product line but is also expected to significantly boost revenue in the second half of the year, enhancing market competitiveness.
- International Market Expansion: In its International Diagnostics business, OraSure has established closer relationships with distribution partners in Africa and has delivered initial orders to one near-shoring partner, indicating accelerated global market positioning and operational capabilities.
- Financial Health: As of the end of Q1, OraSure had zero debt and cash and cash equivalents of $177 million; despite a negative operating cash flow of $14 million, the company anticipates returning to breakeven in operating cash flow by 2027, demonstrating strong financial management.
See More
OraSure (OSUR) Q1 2026 Earnings Transcript
See More
Surge in Options Trading Volume for OraSure and CleanSpark
- OraSure Options Volume: OraSure Technologies Inc. saw options trading volume of 2,076 contracts, equating to approximately 207,600 shares, which represents about 64.5% of its average daily trading volume of 321,695 shares over the past month, indicating strong market interest in its future performance.
- High Strike Demand: Notably, the $2.50 strike call option expiring on July 17, 2026, has seen 2,065 contracts traded today, representing around 206,500 shares, suggesting a bullish sentiment among investors regarding this price point.
- CleanSpark Options Volume: CleanSpark Inc. recorded an options trading volume of 119,991 contracts, translating to approximately 12.0 million shares, which accounts for 60.9% of its average daily trading volume of 19.7 million shares over the past month, reflecting significant market attention on its stock.
- Significant Strike Activity: The $16 strike call option expiring on June 18, 2026, has seen 14,108 contracts traded today, representing about 1.4 million shares, indicating investor confidence in CleanSpark's future growth potential.
See More
OraSure Technologies Schedules Q1 2026 Earnings Call for May 6
- Earnings Call Announcement: OraSure Technologies has scheduled its earnings conference call for Q1 2026 on May 6 at 5 PM ET, highlighting the company's commitment to transparency and investor communication regarding financial results and business developments.
- Webcast Availability: The conference call will be available via webcast on OraSure's investor relations page, requiring investors to register at least 10 minutes prior to the call, which enhances timely information dissemination and investor engagement.
- Company Overview: OraSure focuses on transforming health through actionable insights and decentralized diagnostics, providing innovative testing and sample management solutions that improve healthcare access and quality, underscoring its leadership in rapid diagnostic testing.
- Global Sales Network: OraSure's product portfolio is sold globally to various channels, including clinical laboratories and hospitals, indicating its extensive influence and market penetration within the healthcare industry.
See More
OraSure Partners with Altai Capital, Appoints John D. Bertrand to Board
- Board Transformation: OraSure has entered into a cooperation agreement with activist investor Altai Capital, appointing John D. Bertrand to the board, aiming to enhance governance through regular discussions on financial and strategic matters, thereby boosting investor confidence.
- Shareholder Voting Plan: The company plans to seek shareholder approval to declassify its board at the 2026 annual meeting, a move that will improve board transparency and accountability, potentially attracting more investor interest.
- Activist Investor Impact: Following the agreement, Altai Capital withdrew its director nominations, indicating an improving relationship with OraSure that could facilitate sustainable value growth for the company in the future.
- Potential Acquisition Call: Altai reiterated its call for a potential sale of OraSure last month, suggesting that such a move could potentially double the medical device maker's share price, further driving the company's strategic transformation and market performance.
See More
