OraSure Gains FDA Clearance for Colli-Pee Dx Urine Kit for Four STI Tests
OSUR•OraSure’s DNA Genotek unit received FDA clearance for its Colli-Pee™•Dx Urine Collection Kit to be used with Roche’s cobas 5800, 6800 and 8800 systems for CT, NG, TV and MG testing. The kit enables at-home first-void urine self-collection with proprietary NucleoPrecision™ stabilization technology, supporting high-volume, private STI screening.
1. FDA Clearance Details
OraSure’s FDA clearance covers its Colli-Pee™•Dx Urine Collection Kit for use with Roche’s cobas® 5800, 6800 and 8800 molecular diagnostic platforms to test for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium. The approval enables healthcare providers and laboratories to accept first-void urine specimens collected at home for these four STI targets.
2. Product Benefits and Technology
The Colli-Pee™•Dx kit uses NucleoPrecision™ Technology to stabilize DNA and RNA at ambient temperature, ensuring sample integrity during mail-in workflows. Its volumetric first-void design and non-invasive collection offer a convenient, private patient experience and maintain optimal sample-to-preservative ratios critical for accurate molecular detection.
3. Market Implications and Distribution
With this clearance, OraSure subsidiary DNA Genotek can market the Colli-Pee™•Dx kit directly to clinical labs, healthcare systems and community screening programs. The expansion of at-home self-collection is poised to drive higher test volumes, broaden access to underserved populations and strengthen OraSure’s position in decentralized diagnostic solutions.
