BRAF Testing Gets FDA Clearance: Guardant360 CDx Marks Breakthrough in Colorectal Cancer Diagnosis

In a significant advancement for precision oncology, the FDA has recently cleared Guardant360 CDx as a companion diagnostic for patients with BRAF V600E-mutant metastatic colorectal cancer. This approval underscores the critical role that BRAF testing now plays in guiding targeted therapy selection, enabling clinicians to match patients with the most effective treatment approaches.

Liquid Biopsy Companion Diagnostic Achieves Regulatory Milestone

The Guardant360 CDx test leverages liquid biopsy technology—a blood-based approach to genomic profiling—to detect BRAF V600E mutations and other clinically relevant genetic alterations. Unlike traditional tissue biopsies, this non-invasive method allows for rapid molecular characterization when tumor samples are limited, unavailable, or when urgent treatment decisions are necessary. The approval specifically supports treatment selection with Pfizer’s BRAFTOVI (encorafenib) combined with cetuximab and chemotherapy, representing a validated pathway for BRAF testing in advanced colorectal cancer.

Clinical Trial Evidence Demonstrates Significant Therapeutic Gains

The clearance builds on robust data from Pfizer’s Phase 3 BREAKWATER trial, which evaluated encorafenib-based regimens in treatment-naive patients with BRAF-mutated metastatic disease. The study demonstrated meaningful improvements in objective response rates, progression-free survival, and overall survival compared to standard-of-care approaches. These findings highlight the clinical value of early genomic testing to inform precision treatment decisions in this aggressive malignancy.

Expanding Patient Access Through Blood-Based Genomic Profiling

Guardant360 CDx’s approval represents a paradigm shift toward more accessible molecular diagnostics. By enabling BRAF testing through a simple blood draw, the test streamlines the diagnostic workflow and reduces barriers to genomic profiling. This is particularly advantageous in real-world clinical settings where obtaining adequate tissue samples can be challenging. Helmy Eltoukhy, chairman and co-CEO of Guardant Health, emphasized that this approval reinforces the expanding role of liquid biopsy technology in managing advanced malignancies and strengthens the company’s position across multiple cancer types requiring companion diagnostic testing.