The FDA approved Labcorp’s PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma. Labcorp said the approval enables patient selection for FDA-approved BRAF-targeted therapies, including BRAF inhibitors and BRAF/MEK combination regimens. The NGS-based assay uses a tissue workflow designed to expand access by keeping samples and data in-house, with a reported clinical success rate of 94.4% and a four- to five-day turnaround from nucleic acid isolation to reporting. Labcorp said the ready-to-use kit reduces reliance on external sample shipping required by some laboratory workflows. The decision also highlights the evolving role of molecular diagnostics in speeding targeted therapy access. With Labcorp having acquired the test via its purchase of Personal Genome Diagnostics in 2022, the approval further strengthens its position in oncology testing.