Next-Gen Companion Diagnostic Tests

Labcorp Receives Approval for PGDx Elio Tissue Complete CDx

Labcorp, a global laboratory services company with a significant presence in diagnostics and drug development, has received approval from the U.S. Food and Drug Administration for its PGDx Elio Tissue Complete CDx — a companion diagnostic test that uses next-generation sequencing to detect specific BRAF V600E and V600K variants in tumor tissue from patients with advanced melanoma. The goal of this innovation is to help clinicians determine which individuals may be eligible for treatment with FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combination therapies.

Melanoma, particularly at stage IV, has a historically low five-year survival rate of approximately 16%, making timely and accurate molecular profiling critical for guiding treatment decisions. Labcorp's companion diagnostic test addresses that need by providing a standardized, scalable kit-based solution that can be implemented directly within hospitals and health systems.

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