The FDA cleared OraSure Technologies’ at-home urine sample collection workflow for sexually transmitted infection testing using Roche systems, expanding convenient specimen collection tied to centralized molecular diagnostics. The Colli-Pee urine kit now supports first-void self-collection for testing of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Separately, Guardant Health received FDA approval for its Guardant360 CDx companion diagnostic for Boehringer Ingelheim’s HER2-mutant lung cancer therapy Hernexeos (zongertinib). The decision strengthens the biomarker-to-treatment pathway for patients with unresectable or metastatic non-squamous NSCLC harboring activating HER2 mutations.