Guardant Health said the FDA approved its Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in HER2-mutant advanced non-small cell lung cancer. The approval supports liquid-biopsy testing to identify patients with HER2 tyrosine kinase domain activating mutations for treatment selection. Boehringer received accelerated approval for the indication based on objective response rate and duration of response, and Guardant said the test detects multiple genomic alterations across solid tumors. Guardant also noted this is the 27th companion diagnostic indication for Guardant360 CDx. For biotech and pharma teams, the decision reinforces the growing centrality of broad liquid-biopsy platforms in precision oncology—particularly as targeted therapies expand into genetically defined subpopulations and label language increasingly ties to real-world test performance.