FDA approves Labcorp's BRAF melanoma companion diagnostic

The FDA has granted approval to Labcorp's companion diagnostic for advanced melanoma patients with specific BRAF mutations.

The test, called PGDx elio tissue complete CDx, uses next-generation sequencing to detect BRAF V600E and V600K variants in formalin-fixed, paraffin-embedded tumor samples and can be run in hospitals and labs.

Identification of these mutations helps clinicians select FDA-approved targeted therapies such as Novartis' Tafinlar, Roche's Zelboraf, and BRAF/MEK inhibitor combinations.

Labcorp noted that the kit allows health systems to retain samples and data for future research, and the approval follows a recent earnings report highlighting strength in diagnostics.