Guardant Health Inc. has received U.S. Food and Drug Administration (FDA) approval for its Guardant360 CDx test 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. This marks the first FDA-approved companion diagnostic indication for Guardant360 CDx in colorectal cancer and expands its role in guiding targeted therapy across solid tumors. The approval is supported by data from Pfizer's Phase 3 BREAKWATER trial, which demonstrated improved outcomes in patients treated with encorafenib-based regimens. The Guardant360 CDx test enables non-invasive genomic testing through a blood draw, facilitating timely treatment decisions for patients when tumor tissue is unavailable or insufficient.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Guardant Health Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260122091904) on January 22, 2026, and is solely responsible for the information contained therein.