Guardant Health, Inc. (GH) said Thursday that the U.S. Food and Drug Administration has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). The test is designed to help identify individuals who may benefit from treatment with Pfizer's BRAFTOVI (encorafenib) in combination with cetuximab and chemotherapy, in line with the product's approved labeling.
The accelerated approval was backed by findings from Pfizer's Phase 3 BREAKWATER study, which evaluated encorafenib-based treatment regimens in previously untreated patients with BRAF-mutated mCRC. Results from the trial showed that encorafenib plus cetuximab and mFOLFOX6 chemotherapy delivered significant improvements in objective response rate, progression-free survival, and overall survival versus standard-of-care treatment. The data reinforced the value of early genomic testing to guide targeted therapy decisions in this aggressive disease.
Guardant360 CDx expands access to non-invasive genomic profiling through a simple blood draw, detecting BRAF V600E and other clinically meaningful alterations. The approach can support faster treatment decisions when tumor tissue is limited, unavailable, or when a rapid therapy start is medically necessary.
Helmy Eltoukhy, Guardant Health chairman and co-CEO, said the approval highlights the growing role of liquid biopsy in advanced cancer care and strengthens Guardant360 CDx's companion diagnostic claims across multiple tumor types.
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