The kit-based next-generation sequencing test identifies BRAF variants to guide targeted therapy selection for patients with stage IV disease.
The Food and Drug Administration (FDA) approved Labcorp’s PGDx elio tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma who may benefit from targeted therapies, according to a press release from Labcorp. This follows other recent diagnostic approvals, such as Labcorp’s FDA-approved IHC companion diagnostic for prostate cancer.
The test is designed to identify specific BRAF variants in patients with advanced melanoma. These patients may be eligible for treatment with FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combination regimens.
Melanoma is the deadliest form of skin cancer, with a five-year survival rate of 16% for patients diagnosed with stage IV disease, according to the release. Testing plays a crucial role in managing the disease, with other tools like the DecisionDx-Melanoma gene expression test helping to improve risk prediction beyond standard staging. Targeted therapies are a primary treatment option for patients whose tumors carry a BRAF alteration.
“Advanced melanoma is an extremely aggressive and life‑threatening cancer, but targeted treatments are offering real hope for patients,” says Shakti Ramkissoon, MD, PhD, vice president, medical lead for oncology at Labcorp, in a release. “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.”
Technical Specifications and Lab Implementation
The PGDx elio tissue complete CDx is a qualitative next-generation sequencing-based in vitro diagnostic device. It utilizes high-throughput hybridization-based capture technology with DNA isolated from formalin-fixed paraffin embedded tumor tissue. The panel is capable of detecting single nucleotide variants, small insertions and deletions, copy number amplifications, and translocations.
The diagnostic is approved for use by healthcare professionals across hospitals and clinical laboratories. As a kit-based solution, the companion diagnostic can be implemented directly within hospital systems. This enables organizations to retain samples and data that may inform future clinical research while expanding access to molecular testing, according to Labcorp.
The addition of this diagnostic to the Labcorp precision medicine portfolio—which also includes a consumer genetic health panel for hereditary risk assessment—includes tissue- and liquid-based oncology diagnostics designed to support personalized care. The PGDx elio tissue complete CDx specifically helps clinicians confirm which melanoma patients carry BRAF V600E/K variants to expedite the start of targeted treatment.
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