The U.S. FDA granted approval to Bayer’s oral HER2‑directed kinase inhibitor Hyrnuo (sevabertinib) for adults with advanced HER2‑mutant non‑small‑cell lung cancer, and Thermo Fisher’s Ion Torrent Oncomine Dx Target Test was cleared as the companion diagnostic. Bayer received breakthrough therapy designation and priority review for the filing; Thermo Fisher’s NGS assay will be used to identify patients with activating HER2 kinase domain mutations eligible for Hyrnuo. The approvals position Bayer to compete directly with recently approved HER2‑targeting oral drugs and expand the use of genomic testing in thoracic oncology. Clarification: the companion diagnostic is an FDA‑cleared next‑generation sequencing assay that detects specific tumor mutations to guide therapy selection.