OraSure Technologies received 510(k) clearance from the FDA for an at-home urine collection kit that supports molecular STI testing using Roche automated systems. The Colli-Pee kit is designed for self-collection of first-void urine and incorporates a stabilization chemistry intended to preserve nucleic acids at room temperature until lab processing. The clearance expands practical access to nucleic-acid-based testing for Chlamydia, gonorrhea, trichomoniasis, and Mycoplasma genitalium by enabling prescribed home collection with subsequent lab-based molecular readouts. In parallel, the FDA pathway supports a broader shift toward point-of-access diagnostics and could reduce barriers to screening that are particularly relevant for at-risk populations and community programs.