OraSure seeks FDA 510(k) for 30‑minute CT/NG self‑test and urine kit

OraSure Technologies submitted a 510(k) to the FDA for a rapid, disposable self‑test for chlamydia and gonorrhea built on Sherlock Biosciences’ technology, along with a Colli‑Pee at‑home urine collection device. The CT/NG test pairs self‑collected swabs with a handheld reader and promises results in roughly 30 minutes. OraSure estimates the U.S. CT/NG addressable market exceeds $1.5 billion and framed the filings as steps to decentralize diagnostics and expand rapid, private STI testing outside centralized labs.