Guardant Health Receives FDA Approval for Guardant360 CDx as Companion Diagnostic for BRAFTOVI in BRAF V600E-Mutant Metastatic Colorectal Cancer.

Guardant Health's Guardant360 CDx has received FDA approval as a companion diagnostic for BRAFTOVI (encorafenib) in combination with cetuximab and chemotherapy in patients with BRAF V600E-mutant metastatic colorectal cancer. The approval is supported by data from Pfizer's Phase 3 BREAKWATER trial, which demonstrated the efficacy of encorafenib-based regimens in previously untreated patients with BRAF-mutated mCRC. Guardant360 CDx is a non-invasive genomic testing platform that detects clinically relevant genetic alterations, including BRAF V600E, from a simple blood draw. The approval expands access to non-invasive genomic testing for this high-risk patient population.