The FDA approved Bayer’s oral HER2-directed therapy Hyrnuo (sevabertinib) for adults with locally advanced or metastatic HER2-mutant non‑small-cell lung cancer, and Thermo Fisher’s Ion Torrent Oncomine Dx Target Test earned clearance as the companion diagnostic. Bayer won breakthrough and priority review designations earlier this year; the approvals create a linked drug‑diagnostic commercial path. Thermo Fisher’s authorization lets clinicians identify eligible patients via a next‑generation sequencing (NGS) panel, aligning molecular testing with the new treatment option.