OraSure Technologies, Inc. Announces FDA Clearance that Expands Patient‑Friendly Access to Testing for Sexually Transmitted Infections

BETHLEHEM, Pa., (ZEEST MEDIA) — OraSure Technologies, Inc. (“OraSure”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions today announced U.S. Food and Drug Administration (FDA) clearance of its Colli-Pee™•Dx Urine Collection Kit from its subsidiary DNA Genotek Inc., for use with Roche’s tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) and run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. 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.

This clearance marks a significant advancement in patient-centric diagnostics, combining OraSure’s Colli-Pee™•Dx Urine Collection Kit, which includes NucleoPrecision™ Technology, a proprietary chemistry for DNA and RNA stabilization, with Roche’s cobas® high-throughput molecular testing capabilities. The Colli-Pee™•Dx Urine Collection Kit uses innovative 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 expands 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.

The Colli-Pee™•Dx Urine Collection Kit is designed to collect volumetric, first-void urine, ensuring optimal sample-to-preservative-ratio, a critical factor for STI detection, while offering a simple, non-invasive experience that prioritizes patient convenience and privacy.

“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. “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.”

Enabling Scalable, Decentralized Testing
With FDA clearance, laboratories and health systems can now deploy a fully validated mail-in workflow that supports high-volume molecular STI testing without invasive sample collection methods. The collaboration enables the convenience of at-home urine collection, improves reach to populations in need, and supports public health initiatives focused on early detection and treatment of STIs.

The Colli-Pee™•Dx Urine Collection Kit will be sold by OraSure subsidiary DNA Genotek.

About OraSure Technologies
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information, please visit www.orasure.com.

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