Guardant Health has received U.S. Food and Drug Administration approval for Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI (encorafenib) in combination with cetuximab and chemotherapy.
The accelerated approval is supported by data from BREAKWATER trial, which demonstrated improved objective response rate, progression-free survival, and overall survival with encorafenib-based regimens compared with standard care in previously untreated BRAF-mutant mCRC. The findings reinforce the importance of early genomic testing in this aggressive colorectal cancer subtype.
Guardant360 CDx enables non-invasive, blood-based detection of BRAF V600E mutations, helping clinicians rapidly identify eligible patients when tumor tissue is unavailable, insufficient, or when treatment decisions must be made quickly. This marks the first FDA-approved companion diagnostic use of Guardant360 CDx in colorectal cancer, expanding its role beyond lung and breast cancer.