OraSure Technologies Receives FDA Clearance for Colli-Pee™•Dx Kit

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.