OraSure wins FDA clearance for at-home STI urine collection kit
OraSure Technologies has received FDA clearance for its Colli-Pee Dx Urine Collection Kit, developed by subsidiary DNA Genotek, allowing patients to collect first-void urine samples at home for laboratory testing of four sexually transmitted infections: chlamydia, gonorrhoea, trichomonas vaginalis, and mycoplasma genitalium.
The cleared kit is validated for use with Roche's cobas 5800, 6800, and 8800 molecular diagnostic platforms, giving clinical laboratories a mail-in workflow that feeds directly into high-throughput automated testing infrastructure already deployed at scale across the US.
What the clearance enables
The Colli-Pee Dx kit incorporates OraSure's NucleoPrecision Technology, a proprietary chemistry that stabilises DNA and RNA in urine at ambient temperatures. That thermal stability is the key technical enabler: it removes the need for cold-chain logistics between a patient's home and the receiving laboratory, a requirement that has historically constrained mail-in specimen programmes for nucleic acid amplification tests.
The kit collects a volumetric first-void sample, which the company says preserves a precise sample-to-preservative ratio considered critical for reliable STI detection. OraSure is positioning the product as a non-invasive alternative to clinician-administered swab or catheter-based collection, which remains the standard in many STI screening protocols.
Carrie Eglinton Manner, President and Chief Executive Officer of OraSure, said the clearance "connects people to care that is more accessible, convenient, private, and personalised" and reflects progress on what she described as the company's decentralised diagnostics roadmap.
Market context and competitive landscape
The FDA clearance arrives at a moment of renewed public health focus on STI rates in the United States, where the Centers for Disease Control and Prevention has documented rising incidence of chlamydia, gonorrhoea, and syphilis over successive years. Removing access barriers to testing, particularly for individuals in rural or underserved communities, is a recognised lever for improving case detection and treatment rates.
OraSure is not alone in pursuing decentralised STI diagnostics. A number of companies, including Everlywell and LetsGetChecked, already offer direct-to-consumer STI test kits, though many rely on self-administered swabs and typically partner with third-party laboratories for processing. OraSure's differentiation lies in the validated pairing with Roche's cobas platforms, which are already embedded in large reference laboratories and hospital lab networks, potentially reducing friction for health systems seeking to launch or scale mail-in STI screening programmes.
Roche's cobas franchise remains one of the most widely adopted molecular diagnostics platforms globally, and regulatory clearance for a collection device that feeds into that installed base has genuine commercial reach. The pairing also reinforces a broader industry trend of hardware-agnostic sample collection products being cleared in combination with established laboratory platforms, lowering the validation burden for end users.
For OraSure, the clearance extends a strategy of building out DNA Genotek's collection and stabilisation portfolio beyond its established genomics and oral-fluid applications into regulated in vitro diagnostics. The company said the Colli-Pee Dx kit will be sold through DNA Genotek. No pricing, launch timeline, or commercial partnership terms were disclosed in the announcement.