Labcorp's PGDx elio Tissue Complete CDx Gains FDA Approval as Companion Diagnostic for BRAF-Mutant Advanced Melanoma
核心洞察
The FDA has approved Labcorp (搜索)'s PGDx elio tissue complete CDx (搜索) as a companion diagnostic for identifying BRAF V600E (搜索)/K variants in advanced melanoma (搜索) patients.
The test enables clinicians to determine which patients may benefit from FDA-approved BRAF inhibitors (搜索) and BRAF/MEK inhibitor combination regimens.
Advanced melanoma (搜索) carries a five-year survival rate of just 16% for stage IV disease, underscoring the urgency of targeted treatment access.
The U.S. Food and Drug Administration has approved Labcorp (搜索)'s PGDx elio tissue complete CDx (搜索) as a companion diagnostic to help identify patients with advanced melanoma (搜索) who carry certain BRAF variants and may be eligible for treatment with FDA-approved targeted therapies, the company announced on August 10, 2026.
The approval addresses a critical need in the management of advanced melanoma (搜索), the deadliest form of skin cancer. Patients diagnosed with stage IV disease face a five-year survival rate of just 16%, making timely identification of actionable mutations essential for guiding therapy.
"Advanced melanoma (搜索) is an extremely aggressive and life-threatening cancer, but targeted treatments are offering real hope for patients," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp (搜索). "Labcorp's FDA-approved companion diagnostic improves access to these therapies by allowing clinicians to confirm which patients may be eligible for and can start receiving those treatments as soon as possible."
How the Companion Diagnostic Works
PGDx elio tissue complete CDx (搜索) is a qualitative next-generation sequencing-based in vitro diagnostic device that employs high-throughput hybridization-based capture technology using DNA isolated from formalin-fixed paraffin-embedded tumor tissue. The targeted panel can detect single nucleotide variants, small insertions and deletions, copy number amplifications, and translocations.
As a companion diagnostic, the test specifically identifies BRAF V600E (搜索) and BRAF V600K (搜索) variants in melanoma patients, enabling clinicians to determine eligibility for FDA-approved BRAF inhibitors (搜索) or BRAF/MEK inhibitor combination regimens in accordance with the approved therapeutic product labeling.
Expanding Access Through a Scalable Platform
The kit-based design of PGDx elio tissue complete CDx (搜索) allows it to be implemented directly within hospitals and health systems by qualified healthcare professionals. This decentralized model expands access to high-quality molecular testing while enabling organizations to retain samples and data that may inform future clinical research.
The approval reflects the continued expansion of Labcorp (搜索)'s precision medicine portfolio, which encompasses comprehensive tissue- and liquid-based oncology diagnostics designed to support personalized cancer care.
Clinical Context and Significance
Targeted therapies represent an important treatment option for patients with advanced melanoma (搜索) whose tumors harbor BRAF alterations. By providing a regulatory-approved pathway for identifying these patients, the PGDx elio tissue complete CDx (搜索) aims to streamline clinical decision-making and reduce the time to initiation of appropriate targeted therapy.
Labcorp (搜索), which employs nearly 71,000 people serving clients in approximately 100 countries, provided support for more than 85% of the new drugs and therapeutic products approved by the FDA in 2025 and performed more than 750 million tests for patients worldwide.