OraSure Clears FDA Hurdle for At-Home STI Testing Kit
Event summary
- FDA cleared OraSure’s Colli-Pee™•Dx Urine Collection Kit for use with Roche’s STI tests on June 11, 2026.
- Kit enables at-home, first-void urine collection for Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium.
- Collaboration integrates OraSure’s NucleoPrecision™ Technology with Roche’s cobas® high-throughput systems.
- Designed to expand access for underserved populations and support decentralized testing workflows.
The big picture
This clearance represents a strategic advancement in decentralized diagnostics, aligning with broader trends toward patient-centric healthcare solutions. The integration of OraSure’s sample collection technology with Roche’s molecular testing platforms creates a scalable model for STI screening that could become a benchmark for other infectious disease diagnostics. The move positions OraSure to capture market share in the growing at-home testing segment, particularly among populations facing barriers to traditional healthcare access.
What we're watching
- Market Adoption
- How quickly healthcare providers and patients will embrace at-home STI testing solutions.
- Competitive Response
- Whether competitors will accelerate development of similar decentralized diagnostic solutions.
- Regulatory Expansion
- The pace at which similar clearances might be granted for other diagnostic applications.
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