The FDA approved Labcorp’s PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma. The tissue-based assay is designed to help clinicians select patients for FDA-approved targeted therapies, including BRAF inhibitors and BRAF/MEK combinations. Labcorp said the premarket decision followed an FDA review completed late last month and that the kit’s workflow can deliver results within about four to five days, aiming to expand access versus sending samples out for external NGS processing. The company reported a clinical success rate of 94.4% in melanoma. The next-generation sequencing format uses high-throughput hybridization capture for 505 genes and also supports additional biomarkers such as microsatellite instability and tumor mutation burden. For precision oncology, the approval adds another path to faster, in-house testing and strengthens the regulatory footprint of tissue-based companion diagnostics for melanoma.