Burlington, North Carolina, USA, August 10, 2026
Labcorp has announced that the U.S. Food and Drug Administration (FDA) has approved its PGDx elio® tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma who have specific BRAF variants and may be eligible for FDA-approved targeted therapies. The regulatory milestone expands access to molecular testing that can help clinicians identify patients whose tumors carry BRAF V600E or BRAF V600K variants, supporting treatment decisions involving approved BRAF inhibitors and BRAF/MEK inhibitor combination therapies. The approval strengthens Labcorp’s position in precision oncology and expands its portfolio of diagnostic solutions designed to connect molecular testing with personalized cancer treatment.
FDA-Approved Diagnostic Targets BRAF Variants
Advanced melanoma remains a major clinical challenge, particularly for patients with metastatic disease. According to Labcorp, patients with advanced melanoma whose tumors contain certain BRAF alterations may have access to targeted treatment options. The newly approved PGDx elio tissue complete CDx is designed to help clinicians determine whether a patient’s tumor contains the BRAF V600E or BRAF V600K biomarkers associated with eligible targeted therapies. By providing molecular information about the tumor, the companion diagnostic can support clinicians in identifying patients who may benefit from specific treatment approaches in accordance with approved product labeling.
The diagnostic uses next-generation sequencing (NGS) technology and is designed as a qualitative in-vitro diagnostic device. Its targeted panel can detect multiple types of genomic alterations, including single nucleotide variants, small insertions and deletions, copy number amplifications, and translocations. The technology uses DNA isolated from formalin-fixed, paraffin-embedded tumor tissue, providing a molecular testing approach that can be integrated into established oncology diagnostic workflows.
Scalable Testing Supports Precision Oncology
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Labcorp said the PGDx elio tissue complete CDx is approved for use by qualified healthcare professionals in hospitals and clinical laboratories. As a kit-based companion diagnostic, the solution can be implemented directly within healthcare organizations and health systems, potentially broadening access to molecular testing while allowing institutions to retain patient samples and associated data that may support future clinical research.
The FDA approval also reflects the growing role of companion diagnostics in precision medicine, where molecular characteristics of a tumor can help determine whether a patient is an appropriate candidate for a targeted therapy. For advanced melanoma, identifying actionable BRAF variants can be an important component of treatment selection. Labcorp’s diagnostic approach is therefore positioned to support a more personalized pathway in which laboratory testing helps inform therapeutic decisions.
Labcorp Expands Oncology Diagnostic Portfolio
The addition of the FDA-approved companion diagnostic contributes to Labcorp’s broader oncology and precision medicine portfolio, which includes tissue- and liquid-based diagnostic technologies. The company provides laboratory services intended to support healthcare providers, pharmaceutical companies, researchers, and patients across the drug-development and healthcare ecosystem.
The newly approved test is specifically indicated for melanoma, with BRAF V600E and BRAF V600K identified as the relevant biomarkers and FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combinations listed as the associated therapeutic options. By enabling molecular identification of these variants, PGDx elio tissue complete CDx is intended to help clinicians determine which patients may benefit from targeted treatment. The FDA decision represents an important regulatory milestone for Labcorp and highlights the continuing convergence of molecular diagnostics, biomarker testing, targeted cancer therapy, and precision medicine. For patients with advanced melanoma, broader availability of validated companion diagnostic testing may help healthcare professionals identify appropriate targeted treatment options based on tumor biology.
Source: Labcorp press release
