Guardant Health said the FDA has approved its Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in HER2-mutant advanced non-small cell lung cancer. The liquid biopsy test is intended to identify activating ERBB2 tyrosine kinase domain mutations to guide treatment selection under an accelerated-approval framework based on objective response rate and duration of response. The approval marks the 27th CDx indication for Guardant360 CDx, extending Guardant’s coverage across multiple tumor types. For clinicians and payers, the update reinforces the expanding role of broad liquid biopsy panels in biomarker-driven oncology pathways, particularly where time-sensitive decisions and low tissue availability remain obstacles.