ORASURE TECHNOLOGIES INC

OraSure Technologies, Inc. announced U.S. Food and Drug Administration (FDA) clearance for its Colli-Pee™•Dx Urine Collection Kit, developed by its subsidiary DNA Genotek Inc. This kit is cleared for use with Roche Molecular Systems, Inc. tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. The kit is compatible with Roche's cobas® 5800, 6800, and 8800 molecular diagnostic systems and enables convenient at-home self-collection of first-void urine for both male and female patients.

OraSure Technologies announced U.S. FDA clearance for its Colli-Pee Dx Urine Collection Kit, developed by its subsidiary DNA Genotek Inc. This kit is designed for at-home self-collection of first-void urine for detecting Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium, and is compatible with Roche's cobas molecular diagnostic systems. The clearance represents a significant advancement in patient-centric diagnostics, enabling convenient and private sample collection while maintaining sample integrity at ambient temperatures, thereby expanding access to STI testing.

OraSure Technologies' stockholders approved several key proposals at the 2026 Annual Meeting, including an amendment to declassify the Board of Directors over a three-year period, beginning at the fiscal 2027 annual meeting. They also approved increasing the shares authorized for the 2000 Stock Award Plan by 5,000,000 shares. Additionally, three Class II Directors were elected, Grant Thornton LLP was ratified as the independent auditor, and the advisory vote on executive compensation was approved.

OraSure Technologies reported a net loss of $22.38 million for Q1 2026, a significant increase from $16.04 million in Q1 2025, while net revenues decreased by 6.7% to $27.93 million. The company continued its cost-cutting efforts with a new reduction in workforce in Q1 2026 and repurchased $5.0 million in common stock. Cash and cash equivalents declined to $176.96 million.

OraSure Technologies announced its first quarter 2026 financial results, with total net revenues decreasing 7% year-over-year to $27.9 million. The company reported a GAAP net loss of $22.4 million, or $(0.32) per diluted share, compared to a net loss of $16.0 million in the prior year. Despite the revenue decline and increased loss, OraSure achieved gross margin expansion and maintained a strong balance sheet with $177 million in cash. The company also announced the appointment of John D. Bertrand to its Board of Directors and provided Q2 2026 revenue guidance of $27 million to $30 million.

OraSure Technologies, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 3, 2026. Key proposals include the declassification of the Board of Directors and an amendment to the Stock Award Plan to increase authorized shares by 5 million and extend its term by ten years. The company highlighted strong 2025 performance, including $19 million in cost savings, a strong balance sheet with $199 million in cash, and $15 million returned to shareholders through buybacks, alongside key FDA submissions and an acquisition.

OraSure Technologies, Inc. has scheduled its first quarter 2026 financial results conference call for May 6, 2026, at 5 p.m. ET. The call will cover the company's Q1 2026 financial performance and certain business developments. Investors can access a live webcast of the call on the company's investor relations website, which will also be archived for later viewing.

OraSure Technologies, Inc. entered into a cooperation agreement with Altai Capital Management, L.P., resolving a potential proxy contest. Under the agreement, Altai withdrew its prior nominations and stockholder proposal. The company appointed John D. Bertrand as a Class II director and committed to seeking stockholder approval at the 2026 Annual Meeting to declassify its Board structure, phasing in annual director elections.

OraSure Technologies announced the appointment of John D. Bertrand as an independent director, a healthcare technology executive with over a decade of experience in AI-enabled diagnostics. Concurrently, the company will seek shareholder approval at its 2026 Annual Meeting to declassify its Board of Directors. These developments stem from a Cooperation Agreement with Altai Capital Management, L.P., under which Altai will withdraw its director nominations for the upcoming Annual Meeting.