OraSure Technologies submitted a 510(k) application to the FDA for a rapid, disposable test for Chlamydia trachomatis and Neisseria gonorrhoeae that uses Sherlock Biosciences technology to deliver results in about 30 minutes from self‑collected swabs. The company also filed for clearance of an at‑home Colli‑Pee urine collection device covering multiple STI indications. OraSure described the rapid CT/NG self‑test as a market expansion opportunity versus centralized laboratory testing and cited an addressable market exceeding $1.5 billion. The filings advance OraSure’s strategy to decentralize diagnostics and connect patients to care with faster, private, point‑of‑need testing.