Thermo Fisher received FDA approval for a next-generation sequencing–based companion diagnostic that identifies patients eligible for Bayer’s newly approved HER2-directed lung cancer therapy. The authorization links molecular testing to therapeutic selection for Hyrnuo and will be used to determine patient eligibility for the targeted treatment. The decision expands the commercial role of large-platform NGS diagnostics in oncology and underscores regulators’ continued alignment of precision therapeutics with standardized genomic tests. Thermo Fisher’s CDx will likely be adopted by oncology labs and hospital systems that treat non-small cell lung cancer with HER2 mutations. For clinicians and payers, the approval clarifies the testing pathway for a recently approved therapy and may accelerate patient access to the drug while concentrating testing volume on validated NGS workflows.