September 2026—The FDA has cleared OraSure Technologies’ Colli-Pee Dx Urine Collection kit for use with Roche’s tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium on the Roche Cobas 5800, 6800, and 8800 molecular diagnostic systems. The kit supports at-home self-collection of first-void urine for male and female patients and features NucleoPrecision technology, a proprietary chemistry for DNA and RNA stabilization that maintains urine sample integrity at ambient temperatures.
The Colli-Pee Dx Urine Collection kit will be sold by OraSure subsidiary DNA Genotek.
OraSure Technologies, 800-672-7873