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OraSure in Bethlehem PHOTO/FILE
OraSure receives FDA clearance for home urine collection kit for STIs
Stacy Wescoe//June 11, 2026//
Listen to this articleBethlehem‘s OraSure Technologies Inc. Said the U.S. Food and Drug Administration has given clearance to its Colli-Pee•Dx Urine Collection Kit to its subsidiary DNA Genotek Inc.
The FDA-cleared collection kit supports at-home self-collection of first-void urine, enabling convenient sample collection at-home or in any private setting for both male and female patients.
The kit is for use with Roche‘s tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium and run on Roche’s cobas 5800, 6800, and 8800 molecular diagnostic systems.
In a release, OraSure said the clearance marks a significant advancement in patient-centric diagnostics.
The Colli-Pee•Dx Urine Collection Kit uses stabilization technology to make STI laboratory testing easier by allowing reliable, private at-home urine collection and maintaining urine sample integrity at ambient temperatures.
It can expand access for individuals constrained by mobility, geography, or other barriers; improves patient convenience; and makes population-level screening programs feasible for broader, previously underserved populations.
Healthcare providers can now prescribe, and laboratories can now receive, self-collected urine specimens directly from patients’ homes and process them seamlessly and at scale using Roche’s cobas automated laboratory platforms.
“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 CEO of OraSure. “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.”
