# Guardant Health Inc.’s Guardant360 CDx is a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) The accelerated approval for Braftovi was supported by data from Pfizer Inc.

*biotech · news · 2026-01-22 · Benzinga*

## Key points

- The FDA approved Guardant360 CDx as the first liquid biopsy companion diagnostic for BRAF V600E-mutant mCRC.
- Guardant360 CDx is now FDA-approved for use in colorectal cancer, in addition to lung and breast cancer.
- The BREAKWATER Phase 3 trial showed encorafenib, cetuximab, and chemotherapy significantly outperformed standard care in mCRC.
- Guardant Health recently signed a multi-year collaboration with Merck to support oncology portfolio development using Guardant Infinity Smart.

**Companies:** Pfizer Inc., Merck & Co. Inc., Guardant Health Inc.
**Countries:** United States

[Read the full story on Benzinga](https://www.benzinga.com/news/fda/26/01/50077132/fda-approves-guardant-healths-blood-test-to-guide-treatment-for-advanced-colorectal-cancer)

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