FDA Approves Labcorp Diagnostic for Targeted Melanoma Therapy

The diagnostic tool utilizes next-generation sequencing to detect BRAF V600E and V600K mutations in tumor tissue. By enabling clinicians to rapidly confirm eligibility for BRAF and BRAF/MEK inhibitor regimens, the kit-based solution aims to bypass the delays often associated with off-site molecular testing. Shakti Ramkissoon, vice president and medical lead for oncology at Labcorp, noted that the test is intended to provide clinicians with the clarity needed to initiate targeted therapies as soon as possible.

Designed for integration directly into hospital and clinical laboratory workflows, the platform allows health systems to process samples in-house. This local implementation model not only broadens patient access to precision diagnostics but also enables institutions to retain clinical data for ongoing research. The approval marks a shift in Labcorp’s oncology strategy, expanding a portfolio that currently supports over 85 percent of new drugs and therapeutic products approved by the FDA in 2025.