Labcorp nabs FDA green light for BRAF melanoma diagnostic

MedTech Labcorp nabs FDA green light for BRAF melanoma diagnostic By Ben Adams Aug 10, 2026 9:28am Labcorp melanoma Cancer diagnostics Diagnostics The FDA has signed off on Labcorp’s companion diagnostic for patients with advanced melanoma carrying certain BRAF variants. The PGDx elio tissue complete CDx is now approved in the U.S. to help identify patients with advanced melanoma, the deadliest type of skin cancer, who may benefit from targeted treatments.

The diagnostic is specifically designed to help identify patients with BRAF V600E or V600K variants who may be eligible for FDA-approved targeted therapies. Those include BRAF inhibitors such as Novartis’ Tafinlar and Roche’s Zelboraf for patients with BRAF V600E mutations, as well as BRAF/MEK inhibitor combination regimens for patients with V600E or V600K mutations. The kit-based test can be performed in hospitals and clinical laboratories and uses next-generation sequencing to detect BRAF V600E and V600K mutations in melanoma.

It uses high-throughput hybridization-based capture technology to analyze DNA isolated from formalin-fixed, paraffin-embedded tumor tissue. Related Labcorp posts higher Q2 earnings on strength of diagnostics, lab services; adjusts full-year guidance Around half of all cutaneous melanomas carry a BRAF mutation, with the majority of these being V600E. Labcorp said in an Aug.

10 release that hospitals and health systems using the kit can retain samples and data “that may inform future clinical research.” “Advanced melanoma is an extremely aggressive and life-threatening cancer, but targeted treatments are offering real hope for patients,” said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp, in a statement. “Labcorp's FDA-approved companion diagnostic improves access to these therapies by allowing clinicians to confirm which patients may be eligible for and can start receiving those treatments as soon as possible.” Several other tests already exist to detect BRAF mutations in melanoma, including Foundation Medicine’s FoundationOne CDx and Caris Life Sciences’ MI Cancer Seek, as well as Roche’s cobas 4800 BRAF V600 Mutation Test and bioMérieux’ THxID BRAF test. Labcorp melanoma Cancer diagnostics Diagnostics MedTech