The FDA approved Labcorp’s PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma, enabling patient selection for FDA-approved targeted therapies. Labcorp said the decision, made late last month, expands the ability for clinicians to confirm eligibility and start treatment more quickly. The NGS-based assay uses high-throughput hybrid capture to profile 505 genes and can also detect microsatellite instability and tumor mutation burden. Labcorp reported a 94.4% clinical success rate, with a workflow of roughly four to five days from nucleic acid isolation to reporting, designed to support in-house testing at hospitals and labs. By extending a next-generation testing workflow in a ready-to-use kit format, Labcorp positions the assay to reduce operational friction for melanoma molecular stratification in real-world care settings.