Posted by Michael Wonder on 13 Jun 2026
Guardant Health announces FDA approval of Guardant360 CDx as companion diagnostic for Boehringer Ingelheim’s Hernexeos
11 June 2026 - Guardant Health today announced that the US FDA has approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2) 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 (ERBB2) tyrosine kinase domain activating mutations who may be eligible for treatment with Hernexeos.
