OraSure Technologies received FDA 510(k) clearance for an at-home urine sample collection kit for sexually transmitted infection (STI) testing on Roche systems. The Colli-Pee kit supports self-collection of first-void urine followed by molecular detection for multiple pathogens, with room-temperature stabilization using OraSure’s NucleoPrecision chemistry. The clearance is intended to expand access to screening programs by enabling prescriptions for home collection and direct shipping of specimens to laboratories. Guardant Health also secured an FDA approval for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s HER2-mutant lung cancer drug Hernexeos, marking another broadening of liquid-biopsy-guided oncology decisions.