FDA Approves Guardant360 CDx for HER2-Mutant Lung Cancer Detection

Guardant Health's Guardant360 CDx assay has received accelerated FDA approval. This liquid biopsy test will function as a companion diagnostic for Boehringer Ingelheim's drug, Hernexeos, specifically identifying patients with HER2-mutant advanced non-small cell lung cancer. This approval enables targeted therapy for eligible patients and marks the 27th companion diagnostic indication for the Guardant360 CDx.