FDA Clears Guardant360 CDx BRAF Test for Precision Cancer Care

Guardant Health has announced that the U.S. Food and Drug Administration has approved its Guardant360 CDx BRAF test as a companion diagnostic tool for metastatic colorectal cancer (mCRC) patients with BRAF V600E mutations. This approval represents a significant milestone in precision oncology, enabling physicians to identify which patients are most likely to benefit from targeted therapy with Pfizer’s BRAFTOVI (encorafenib) combined with cetuximab and chemotherapy.

Advancing Precision Treatment in Metastatic Colorectal Cancer

The FDA’s decision was supported by compelling data from Pfizer’s Phase 3 BREAKWATER clinical trial. The study demonstrated that encorafenib-based treatment delivered substantial improvements across multiple efficacy measures compared to standard care. Patients receiving encorafenib plus cetuximab and mFOLFOX6 chemotherapy showed significant gains in objective response rate, progression-free survival, and overall survival. These findings underscore the critical importance of early genomic testing in guiding treatment decisions for this aggressive malignancy.

Clinical Evidence Behind the BRAF Test Approval

The BREAKWATER trial enrolled previously untreated patients with BRAF-mutated mCRC and evaluated various encorafenib-based regimens. The robust efficacy data validated the clinical utility of identifying BRAF V600E mutations before treatment initiation. By enabling rapid mutation detection, the BRAF test allows oncologists to accelerate treatment planning without waiting for traditional tissue biopsy results.

Liquid Biopsy Revolutionizes Diagnostic Access

Guardant360 CDx distinguishes itself by leveraging non-invasive liquid biopsy technology—requiring only a simple blood draw rather than tissue extraction. This approach addresses a critical clinical gap: many advanced cancer patients have limited or unavailable tumor tissue. The liquid-based genomic profiling capability detects BRAF V600E mutations and other clinically actionable alterations with high sensitivity. When rapid therapy initiation is medically urgent, this blood-based diagnostic provides faster turnaround times compared to conventional biopsy procedures.

Expanding the Companion Diagnostic Portfolio

Helmy Eltoukhy, Chairman and co-CEO of Guardant Health, emphasized that this milestone highlights the expanding role of liquid biopsy technology in advanced cancer management. The approval strengthens Guardant360 CDx’s position as a multi-indication companion diagnostic platform. Beyond metastatic colorectal cancer, the BRAF test opens doors to improved diagnostic strategies across multiple cancer types where BRAF mutations drive disease progression.

This regulatory clearance reflects the broader shift toward genomic-driven oncology, where mutation-specific testing and targeted therapy combinations offer patients measurable survival advantages and improved treatment outcomes.