Labcorp received FDA approval for PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma, supporting patient selection for targeted therapies and BRAF/MEK inhibitor regimens. The company said the decision enables clinicians to confirm eligibility faster and start treatments sooner. The assay uses high-throughput, hybridization-based capture sequencing covering 505 genes and can also identify microsatellite instability and tumor mutation burden. Labcorp reported a clinical success rate of 94.4% and said the workflow can be completed in four to five days from nucleic acid isolation to reporting. Labcorp framed the kit format as designed to expand access versus sending samples out for testing, allowing health systems to keep samples and data in-house. The test was acquired through Labcorp’s 2022 purchase of Personal Genome Diagnostics.