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News  ›  GlobeNewswire Inc.

OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

GlobeNewswire Inc. Logo GlobeNewswire Inc. By Na
OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

OraSure Technologies announced the submission of two FDA applications at the end of 2025: one for a rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) that delivers results in approximately 30 minutes, and another for its Colli-Pee at-home urine collection device for STI testing. The CT/NG test addresses a market opportunity exceeding $1.5 billion, with the company positioning these submissions as key milestones in its strategy to decentralize diagnostics and improve healthcare accessibility.

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OSUR   positive

The company achieved significant regulatory milestones by submitting two FDA applications for innovative diagnostic products addressing a large market opportunity ($1.5B+ for CT/NG). The submissions demonstrate progress on the innovation roadmap and represent strategic advancement in decentralized diagnostics, which should support future revenue growth and market expansion.