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OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review
Globenewswire· 2026-01-05 13:00
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]