FDA Approves Labcorp's PGDx Elio Tissue Complete CDx for Advanced Melanoma

The US Food and Drug Administration (FDA) has approved Labcorp’s PGDx elio tissue complete CDx as a companion diagnostic for identifying patients with advanced melanoma who have certain BRAF V600E or V600K variants and may benefit from FDA-approved targeted therapies.¹ These alterations may identify patients eligible for treatment with FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combination regimens, according to the company’s announcement.

Melanoma is the deadliest form of skin cancer, with a 5-year survival rate of 16% for patients diagnosed with stage IV disease.² Targeted therapies represent an important treatment option for patients with advanced melanoma whose tumors have BRAF alterations. The newly approved companion diagnostic is intended to help clinicians determine which patients have the BRAF V600E/K variants associated with eligibility for these therapies.

"Advanced melanoma is an extremely aggressive and life‑threatening cancer, but targeted treatments are offering real hope for patients," Shakti Ramkissoon, MD, PhD, vice president and medical lead for oncology at Labcorp, said in the press 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."¹

Assay Technology and Capabilities

PGDx elio tissue complete CDx is a qualitative, next-generation sequencing-based in vitro diagnostic device. The test uses high-throughput hybridization-based capture technology with DNA isolated from formalin-fixed, paraffin-embedded tumor tissue.

Although the companion diagnostic indication focuses on BRAF V600E and V600K, the assay uses a broader 505-gene panel. The targeted panel can detect several types of genomic alterations, including single-nucleotide variants, small insertions and deletions, copy number amplifications, and translocations.

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The platform also incorporates tumor mutational burden and microsatellite instability assessment. For the melanoma companion diagnostic indication, the test is intended to identify patients who may benefit from the targeted therapies listed in the corresponding approved therapeutic product labeling.

Diagnostic Performance and Workflow

Labcorp reported positive percent agreement of 98.3% for BRAF V600E and 94.7% for BRAF V600K, with negative percent agreement of 99.2% and 100%, respectively. The reported limit of detection is a variant allele frequency of 3.1% for BRAF V600E and 4.7% for BRAF V600K. The clinical sample pass rate for melanoma FFPE samples is 94.4%.

The test is approved for use by qualified health care professionals in hospitals and clinical laboratories. Labcorp said the kit-based format can be implemented within hospitals and health systems, potentially expanding access to molecular testing. The kitted workflow and pipeline output can provide variant reporting in approximately 4 to 5 days after nucleic acid isolation, although this timeframe does not include DNA extraction or downstream processing.

Clinical Implications

The company also noted that the approach allows organizations to retain tumor samples and associated data that could be used to support future clinical research. The approval adds to Labcorp’s precision medicine portfolio, which includes tissue- and liquid-based oncology diagnostics intended to support personalized cancer care.

For dermatology clinicians involved in the care of patients with advanced melanoma, the approval establishes PGDx elio tissue complete CDx as a companion diagnostic to identify melanoma patients with BRAF V600E or V600K mutations who may benefit from targeted therapies in accordance with the approved therapeutic product labeling.

References

1. Labcorp Announces FDA Approval of Companion Diagnostic Supporting Patients with Advanced Melanoma. News release. PR Newswire. Published August 10, 2026. Accessed August 10, 2026. https://www.prnewswire.com/news-releases/labcorp-announces-fda-approval-of-companion-diagnostic-supporting-patients-with-advanced-melanoma-302846587.html

2. SEER Training Modules: Five-Year Survival Rates. U.S. National Institutes of Health, National Cancer Institute. Accessed August 10, 2026. https://training.seer.cancer.gov.