BETHLEHEM, Pa., Feb. 10, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (“OraSure”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today 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, enabling individuals to find out their HIV status with a sim ...

Core Viewpoint - OraSure Technologies, Inc. is set to hold its earnings conference call for the fourth quarter of 2025 on February 25, 2026, at 5 p.m. ET, which will cover financial results and business developments [1]. Company Overview - OraSure Technologies, Inc. focuses on transforming health through actionable insights and decentralizing diagnostics to enhance healthcare access [3]. - The company aims to improve the quality and value of healthcare by providing innovative testing and sample management solutions [3]. - OraSure, along with its subsidiaries, is a leader in developing, manufacturing, and distributing rapid diagnostic tests and sample collection devices for critical medical conditions [3]. - The company's products are sold globally to various entities, including clinical laboratories, hospitals, and direct consumers [3].

Core Viewpoint - OraSure Technologies, Inc. is facing a board election challenge as Altai Capital has nominated two candidates, including its founder Rishi Bajaj, for the Board of Directors at the upcoming 2026 Annual Meeting of Stockholders [1]. Group 1: Board Composition and Engagement - OraSure's Board has engaged extensively with Altai Capital, interviewing Mr. Bajaj for a potential board position but ultimately selecting an alternative candidate [2]. - The Board emphasizes its strong, independent, and engaged composition, having refreshed significantly since 2022 with seven directors departing and three new independent directors added, including healthcare investor Steven K. Boyd [3]. Group 2: Nominations and Proxy Statement - The Nominating and Corporate Governance Committee, along with OraSure's Board, will review Altai's nominations and will present their recommendations in a definitive proxy statement to be filed with the SEC [4]. - Shareholders are not required to take any action at this time regarding the nominations [4]. Group 3: Company Overview - OraSure Technologies, Inc. specializes in point-of-need and home diagnostic tests, aiming to improve healthcare access, quality, and value through innovative testing and sample management solutions [6]. - The company operates globally, providing products to various sectors including clinical laboratories, hospitals, and direct consumers [6].

Core Insights - OraSure Technologies (OSUR) has submitted two applications to the FDA for at-home tests for sexually transmitted infections (STIs), including a rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae, and the Colli-Pee device for urine sample collection [1][8] Company Developments - The submissions are part of OraSure's strategy to decentralize diagnostics, making STI testing more accessible and convenient for patients [2] - The company aims to launch user-friendly diagnostic tools by 2026, enhancing testing availability outside of hospitals and labs [2] - Following the announcement, OSUR shares increased by 3.8%, although the stock has seen a 19% decline over the past six months [3][4] Market Position and Growth Potential - The FDA submissions are expected to support recurring revenues and strengthen OraSure's position in the at-home diagnostics market [4] - The market for CT/NG testing exceeds $1.5 billion, with a significant portion still conducted in centralized laboratories, presenting growth opportunities for at-home testing solutions [11] - The home diagnostics market is projected to reach $6.91 billion by 2025, with a CAGR of 5.26% through 2034, driven by increasing demand for convenient home testing [12] Product Details - The rapid molecular CT/NG self-test provides results in about 30 minutes and is designed for over-the-counter use, requiring no external power source [9] - The Colli-Pee device facilitates private urine collection at home and is being developed in collaboration with a leading diagnostics platform provider [10]

Core Insights - OraSure Technologies, Inc. has submitted two applications to the FDA for a rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae, and for its Colli-Pee™ at-home urine collection device for STIs, marking significant progress in their innovation roadmap [1][2] Group 1: Product Development - The rapid self-test for CT/NG is based on the Sherlock molecular diagnostics platform, providing results in approximately 30 minutes using a self-collected swab, with a total addressable market exceeding $1.5 billion [2] - The Colli-Pee™ device is designed for at-home urine collection, aligning with patient preferences for private and convenient testing, and aims to expand access to testing for multiple STI indications [3] Group 2: Strategic Vision - The company aims to decentralize diagnostics, making healthcare more accessible, convenient, private, and personalized, while continuing to execute its strategy to create value for stakeholders [2] - OraSure Technologies, Inc. is a leader in rapid diagnostic tests and sample management solutions, with a global portfolio sold to various healthcare entities, including clinical laboratories and direct consumers [4]

Core Viewpoint - OraSure Technologies, Inc. is facing a potential board nomination challenge from Altai Capital, which intends to nominate two candidates for the Board of Directors at the 2026 Annual Meeting of Stockholders [1][5]. Group 1: Board Composition and Shareholder Engagement - The OraSure Board and management are focused on shareholder value creation and have engaged in discussions with Altai Capital regarding board composition [2][3]. - The Board has undergone significant refreshment over the past three years, with seven directors departing and three new independent directors added, including Steven K. Boyd in October 2025 [3]. - The Board has offered to engage further with Altai Capital, but Altai has not accepted these invitations [2]. Group 2: Strategic Initiatives and Financial Position - OraSure is executing a strategy to decentralize diagnostics and improve performance, including a $40 million share repurchase program initiated earlier this year [4]. - The company maintains a strong cash position with $216 million on the balance sheet as of September 30, 2025, and has no debt [7]. - OraSure is consolidating operations and insourcing manufacturing to improve margins while exiting unprofitable business lines [7]. Group 3: Future Plans and Product Development - The company is advancing its innovation roadmap with anticipated FDA submissions for new diagnostic products, including the Sherlock rapid molecular self-test and HEMAcollect PROTEIN blood collection tube [7]. - OraSure aims to strengthen its portfolio and focus on high-growth opportunities across diagnostics and sample management solutions [7].

Summary of OraSure Technologies FY Conference Call Company Overview - **Company**: OraSure Technologies (NasdaqGS: OSUR) - **Event**: FY Conference Call on November 19, 2025 - **Key Speakers**: Ken McGrath (CFO), Jason Plagman (VP of Investor Relations) Industry Insights - **Industry**: Healthcare, specifically in rapid diagnostics and sample management - **Market Size**: The STI market, particularly for chlamydia and gonorrhea, is valued at **$1.5 billion** [22][50] - **International Business**: Revenue in the low to mid **$30 million** range, with a noted slowdown due to funding uncertainties [40][42] Core Points and Arguments 1. **Product Roadmap**: - Excitement around the acquisition of Sherlock, focusing on molecular diagnostics and rapid point-of-care testing [22][23] - Upcoming FDA submissions for the ColiP device for STIs and the Sherlock CT/NG product [23][47] - Anticipated revenue growth from the CT/NG test, projected to be the largest product in 3-5 years [50] 2. **Financial Performance**: - 2025 viewed as a transition year due to uncertainties in government funding [24][26] - Cash position of **$216 million** as of Q3, allowing for flexibility in capital allocation [82][90] - Share buyback program of **$40 million** over two years initiated due to favorable return on invested capital [82][99] 3. **Operational Efficiency**: - Focus on strengthening the core business to achieve break-even cash flow [25][26] - Streamlining operations and diversifying customer base to mitigate risks associated with public health funding [27][32] 4. **Growth Strategy**: - Emphasis on innovation and expanding product offerings in diagnostics and sample management [35][70] - Plans to diversify into blood and other sample types, enhancing capabilities in proteomics and liquid biopsy [34][74] 5. **Market Dynamics**: - Recognition of the value of diagnostics and treatment amidst funding disruptions [40][43] - Positive outcomes from the Together Take Me Home program, which found twice as many positive patients compared to normal channels [43] Additional Important Insights - **Governance**: Strengthened board with new members bringing diverse expertise [28][29] - **COVID-19 Impact**: Lessons learned from the pandemic include enhanced capacity and automation, which are now leveraged for current operations [89][90] - **Future Outlook**: Anticipation of profitable growth driven by new product launches and market expansion in STIs, infectious diseases, and wellness [100] Conclusion OraSure Technologies is positioned for growth with a strong focus on innovation, operational efficiency, and market expansion. The company is navigating through a transition year while maintaining a solid cash position and a strategic roadmap for future product launches.

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Core Insights - OraSure Technologies reported a quarterly loss of $0.13 per share, which was better than the Zacks Consensus Estimate of a loss of $0.16, representing an earnings surprise of +18.75% [1] - The company posted revenues of $27.09 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 7.05% and down from $39.92 million year-over-year [2] - OraSure shares have declined approximately 28.8% year-to-date, contrasting with the S&P 500's gain of 15.1% [3] Financial Performance - Over the last four quarters, OraSure has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.15 on revenues of $31.22 million, and for the current fiscal year, it is -$0.67 on revenues of $121.53 million [7] Market Outlook - The company's stock is currently rated Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] - The Medical - Products industry, to which OraSure belongs, is currently ranked in the bottom 40% of over 250 Zacks industries, which may negatively impact stock performance [8]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $27.1 million, with core revenue at $27.0 million, including diagnostics revenue of $14.5 million and sample management revenue of $10.3 million [4][16] - GAAP gross margin in Q3 was 43.5%, while non-GAAP gross margin was 44.2%, slightly better than expectations due to lower scrap expenses [16][17] - GAAP operating loss in Q3 was $16.1 million, and non-GAAP operating loss was $12.7 million [17] Business Line Data and Key Metrics Changes - International diagnostics revenue is expected to be in the low to mid-$30 million range for the full year 2025, representing a decline of approximately 20% compared to 2024 [6] - U.S. diagnostics business is projected to generate revenue in the low to mid-$30 million range for 2025, indicating a low single-digit percentage decline compared to 2024 [8] - Sample management solution revenue is expected to be in the high $30 million range for the full year, approximately flat compared to 2024, excluding the impact of a decline in orders from a large consumer genetics customer [9][10] Market Data and Key Metrics Changes - The international diagnostics business experienced a slower pace of orders for HIV tests in Q3, as partners worked through existing inventory amid funding environment changes [5] - The U.S. public health customers are facing significant reductions in staffing and budgetary uncertainty, impacting the diagnostics market [7] Company Strategy and Development Direction - The company is focused on strategic transformation to position for growth in 2026, expanding and diversifying its product portfolio and customer relationships [4] - The acquisition of Biomedomics aims to enhance the diagnostic portfolio with SickleScan, targeting underserved markets for sickle cell disease testing [6][18] - The company is investing in internal R&D and partnerships to accelerate profitable growth and leverage existing capabilities [4] Management's Comments on Operating Environment and Future Outlook - Management views 2025 as a transition year, with optimism about pipeline opportunities in attractive markets to drive growth in 2026 and beyond [5] - The company is confident in returning the sample management business to growth in 2026, supported by advancements in genomic sequencing and international market trends [10] Other Important Information - The Together Take Me Home program for HIV self-tests has been renewed, with expected revenue recognition of approximately $1.8 million in Q4 [8] - The company ended Q3 with zero debt and total cash and cash equivalents of $216 million, with negative operating cash flow of $10 million [17] Q&A Session Summary Question: Discussion on Biomedomics acquisition - The acquisition aligns with the company's portfolio for rapid diagnostic testing in underserved markets, leveraging existing strengths in Africa and Latin America [23][24] Question: Insights on gross margins and operating expenses - Gross margins exceeded expectations due to lower scrap expenses, while operating expenses were in line with spending focused on innovation [24][25]