Labcorp (NYSE: LH), a provider of comprehensive laboratory services, disclosed on Monday that it has received U.S. Food and Drug Administration approval for its PGDx elio tissue complete CDx as a companion diagnostic to identify patients with advanced melanoma carrying certain BRAF variants who may benefit from targeted therapies.
This test is designed to identify BRAF V600E/K variants, helping clinicians determine which patients may be eligible for FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combinations.
The kit-based diagnostic can be implemented by qualified healthcare professionals in hospitals and clinical laboratories, supporting broader access to molecular testing. The approval expands Labcorp's precision medicine portfolio of tissue- and liquid-based oncology diagnostics.
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