OraSure Receives FDA Clearance for At‑Home STI Testing Kit

OraSure Technologies Inc (NASDAQ: OSUR) announced that the U.S. Food and Drug Administration granted clearance for its at‑home urine collection kit designed for sexually transmitted infection (STI) testing. The cleared product, the Colli‑Pee Dx Urine Collection Kit, is intended to be used in conjunction with Roche’s cobas molecular diagnostic platforms (models 5800, 6800 and 8800). The kit enables patients—both male and female—to collect a first‑void urine sample at home, which can then be mailed to a laboratory for analysis.

The kit incorporates OraSure’s proprietary NucleoPrecision Technology, a chemistry that stabilises DNA and RNA in the specimen, preserving sample integrity at ambient temperatures. This allows laboratories to receive self‑collected specimens directly from patients’ homes without the need for refrigerated transport. The collection system is engineered to capture a volumetric first‑void urine sample and maintain an optimal sample‑to‑preservative ratio, which is critical for accurate detection of the targeted pathogens.

Regulatory clearance authorises the kit to detect four STI-causing organisms: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium. Healthcare providers may prescribe the kit, and laboratories can process the specimens using Roche’s automated cobas platforms, supporting a high‑volume, mail‑in workflow for molecular STI testing.

Carrie Eglinton Manner, President and Chief Executive Officer of OraSure, stated that the FDA clearance “connects people to care that is more accessible, convenient, private, and personalized.” She highlighted that the approval enables laboratories and health systems to deploy a scalable mail‑in testing workflow, facilitating broader access to STI diagnostics.

OraSure will market the Colli‑Pee Dx kit through its subsidiary DNA Genotek. The company, headquartered in Bethlehem, Pennsylvania, focuses on point‑of‑need and home diagnostic tests as well as sample management solutions.

Following the announcement, OraSure’s shares rose 4.1% in pre‑market trading on Wednesday, 11 June 2026.