At-Home Urine Collection Kit Enables High-Throughput STI Screening

Many patients face logistical or privacy barriers that limit participation in testing programs. A new system now enables at‑home first‑void urine collection with ambient stabilization and high‑throughput laboratory analysis for multiple pathogens.

OraSure Technologies’ (Bethlehem, PA, USA) Colli-Pee Dx Urine Collection Kit, developed by its subsidiary DNA Genotek, has received U.S. Food and Drug Administration (FDA) clearance for use with Roche assays for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium on the cobas 5800, 6800, and 8800 molecular diagnostic systems. The clearance supports self-collection of first‑void urine at home or in other private settings for both male and female patients. The kit will be sold by DNA Genotek.

The collection device incorporates NucleoPrecision Technology, a proprietary chemistry that stabilizes DNA and RNA, maintaining urine sample integrity at ambient temperatures. Its volumetric design targets a defined first‑void volume to achieve an optimal sample‑to‑preservative ratio, described as a critical factor for sexually transmitted infection (STI) detection. By combining reliable at‑home collection with stabilization, the system is intended to simplify laboratory processing without invasive collection methods.

Following FDA clearance, healthcare providers can prescribe the kit and clinical laboratories can receive patient‑collected urine specimens directly from the home for processing on cobas automated platforms. Laboratories and health systems can deploy a fully validated mail‑in workflow that supports high‑volume molecular STI testing, expands reach to individuals constrained by mobility or geography, and supports public health screening initiatives. The approach aims to preserve patient convenience and privacy while enabling scalable, centralized analysis.

“This clearance connects people to care that is more accessible, convenient, private, and personalized. It showcases what’s possible when you design solutions around real-life patient behavior,” said Carrie Eglinton Manner, President and Chief Executive Officer of OraSure Technologies. “We are committed to delivering user-friendly tests and collection devices that can be conveniently used in decentralized settings, and this clearance reflects meaningful progress on our innovation roadmap.”