OraSure Gets FDA Clearance for At-Home Urine Collection Kit Used With Roche Tests
OraSure Technologies said the FDA cleared its Colli-Pee Dx Urine Collection Kit, made by subsidiary DNA Genotek, for use with Roche Molecular Systems tests for four sexually transmitted infections run on Roche's cobas 5800, 6800 and 8800 systems. The kit supports at-home self-collection of first-void urine for male and female patients. The filing does not provide financial figures or a sales outlook tied to the clearance.
Key points
- FDA clearance announced June 11, 2026, for the Colli-Pee Dx Urine Collection Kit from DNA Genotek Inc.
- Cleared for use with Roche tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium
- Compatible with Roche cobas 5800, 6800 and 8800 molecular diagnostic systems
- Kit supports at-home self-collection of first-void urine for male and female patients
The filing
Written by AI on Nov 9, 2026, 8:36 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on June 11, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.