Labcorp’s companion diagnostic (CDx) to identify advanced melanoma patients with certain BRAF variants who may benefit from targeted therapies has secured US Food and Drug Administration (FDA) approval.

Approved for use across hospitals and clinical laboratories, the North Carolina-based company’s PGDx elio tissue complete CDx is a next-generation sequencing (NGS) in vitro diagnostic (IVD) that is designed to detect BRAF V600E and V600K melanoma mutations – both melanoma patient cohorts who may benefit from treatment with BRAF inhibitors and BRAF/MEK inhibitor combination regimens.

Melanoma is the deadliest form of skin cancer, with a five‑year survival rate of 16% for patients diagnosed with stage IV disease. Around 50% of melanomas harbour a BRAF mutation, with the BRAF V600E mutation representing the most frequent type, making up around 75% to 90% of all BRAF V600 changes. Meanwhile, V600K is the second most common mutation, accounting for between 5% and 30% of cases.