Guardant Health announced FDA approval of its Guardant360 CDx assay as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in adults with HER2-mutant advanced NSCLC. The liquid biopsy test is intended to identify HER2 tyrosine kinase domain activating mutations to determine patient eligibility. The approval covers use in tumors with unresectable or metastatic non-squamous NSCLC harboring the specified HER2 alterations. The drug’s indication received accelerated approval based on objective response rate and duration of response, and Guardant noted the CDx is designed to support timely biomarker-driven treatment decisions. With this action, Guardant said the Guardant360 CDx has accumulated 27 companion diagnostic indication approvals. Vicky Brown, Boehringer Ingelheim’s US therapeutic area head for oncology and emerging areas, said the test helps connect eligible patients to targeted therapy when decisions matter most. This matters for precision oncology operations: companies are increasingly bundling companion diagnostics and targeted therapies to reduce the “biomarker gap” between discovery and clinic implementation.