The FDA approved Guardant Health’s Guardant360 CDx blood test as a companion diagnostic for Pfizer’s encorafenib (Braftovi) combination regimen in BRAF V600E‑mutant metastatic colorectal cancer, based on BREAKWATER phase 3 data. Guardant360 will be permitted to identify patients via circulating tumor DNA for selection and resistance monitoring in that therapy setting. Guardant’s approval adds to a growing list of liquid biopsies cleared as companion diagnostics and underscores regulators’ willingness to accept ctDNA‑based selection in first‑line settings. The decision expands precision‑medicine options for community oncology settings where tissue biopsies can be challenging and supports the case for broader ctDNA adoption in trial design and clinical care.