Guardant Health received FDA approval for 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 identifies HER2 tyrosine kinase domain activating mutations to determine patient eligibility for the targeted therapy. The approval marks Guardant360 CDx’s 27th companion diagnostic indication, reinforcing demand for actionable biomarker tests that can accelerate treatment decisions in oncology.