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Guardant Health receives FDA approval for Guardant360 CDx in colorectal cancer

Guardant Health (GH) announced that the U.S. Food and Drug Administration has approved Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Braftovi in combination with cetuximab and chemotherapy. The approval was supported by data from Pfizer’s Phase 3 BREAKWATER trial. Guardant stated this is the first FDA-approved companion diagnostic for Guardant360 CDx in colorectal cancer.

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