Guardant Health secured FDA approval for its Guardant360 CDx blood test as a companion diagnostic to identify BRAF V600E‑mutant metastatic colorectal cancer patients eligible for Pfizer’s encorafenib (Braftovi) plus cetuximab and chemotherapy. The decision was supported by the Phase 3 BREAKWATER trial, which demonstrated improved response rate, progression‑free survival and overall survival with the targeted regimen. Guardant said the approval expands Guardant360 CDx’s companion‑diagnostic footprint across multiple tumor types.