OraSure Technologies won FDA 510(k) clearance for its Colli-Pee urine sample collection kit enabling at-home self-collection followed by molecular STI testing on Roche systems. The cleared workflow supports screening expansion by letting patients collect first-void urine samples at home that then feed lab-based molecular diagnostics. Separately, Guardant Health received FDA approval for its Guardant360 CDx assay as a companion diagnostic for Boehringer Ingelheim’s zongertinib (Hernexeos) in adults with HER2-mutant advanced non-small cell lung cancer. The accelerated approval linkage ties assay performance to eligibility selection for targeted therapy in a genomics-defined subgroup. Both moves highlight the industry’s continued reliance on sample-to-result workflows and validated biomarkers, with regulators continuing to formalize the diagnostic scaffolding around precision oncology and broad infectious disease screening.