Guardant Health Receives FDA Approval for Guardant360 CDx as Companion Diagnostic for Hernexeos
Guardant Health announced that the U.S. Food and Drug Administration, FDA, has approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's Hernexeos, the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer as an initial treatment option. The approval enables Guardant360 CDx, a liquid biopsy test that analyzes circulating tumor DNA from a simple blood draw, to identify patients with HER2 tyrosine kinase domain activating mutations who may be eligible for treatment with Hernexeos.
