OraSure's Colli-Pee Dx Urine Collection Kit Receives FDA Clearance

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.