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 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].