On Aug. 10, 2026, Labcorp announced that the U.S. Food and Drug Administration (FDA) had approved Labcorp’s PGDx elio® tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies.

Melanoma is the deadliest form of skin cancer, with a five‑year survival rate of just 16%opens in a new tab for patients diagnosed with stage IV disease. However, targeted therapies are an important treatment option for patients with advanced melanoma whose tumors have a BRAF alteration. As a companion diagnostic, PGDx elio tissue complete CDx helps clinicians identify which melanoma patients carry these BRAF V600E/K variants and may benefit from treatment with FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combination regimens.

Labcorp’s PGDx elio tissue complete CDx is approved for use by qualified healthcare professionals across hospitals and clinical laboratories, supporting broader patient access to high-quality molecular testing. As a kit-based solution, the companion diagnostic can be implemented directly within hospitals and health systems, expanding access to testing while enabling organizations to retain samples and data that may inform future clinical research.