FDA Approves PGDx Elio Tissue Complete CDx for Advanced Melanoma

The FDA has approved Labcorp’s PGDx elio® tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma who carry certain BRAF variants and may benefit from FDA-approved targeted therapies, according to a news release from Labcorp.¹

The test is approved to detect BRAF V600E and V600K mutations in melanoma tissue, allowing clinicians to identify patients who may be eligible for treatment with FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combination regimens.

Melanoma prognosis is closely tied to stage at diagnosis.² According to the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Training website, the 5-year relative survival rate across all stages is 90.5%, ranging from 97.6% for localized (stage I-II) disease down to 60.3% for regional (stage III) disease and 16.2% for distant (stage IV) disease. Approximately 83% of melanomas are diagnosed at a localized stage.

“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.¹ “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.”

PGDx elio tissue complete CDx is a qualitative next-generation sequencing (NGS)-based in vitro diagnostic device.³ It uses high-throughput hybridization-based capture technology on DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue. The targeted panel can detect single nucleotide variants, small insertions and deletions, copy number amplifications, and translocations across 505 genes. It also reports tumor mutational burden (TMB) and microsatellite instability (MSI) status.

In melanoma samples, the assay demonstrated a positive percent agreement of 98.3% for BRAF V600E disease and 94.7% for BRAF V600K, with a negative percent agreement of 99.2% and 100%, respectively. The limit of detection was a variant allele frequency of 3.1% for BRAF V600E and 4.7% for BRAF V600K. The test had a clinical pass rate of 94.4% in melanoma samples, with results available 4 to 5 days after nucleic acid isolation.

The companion diagnostic is approved for use by qualified health care professionals in hospitals and clinical laboratories. As a kit-based solution, PGDx elio tissue complete CDx can be implemented within hospitals and health systems. According to Labcorp, this supports broader access to high-quality molecular testing while allowing organizations to retain samples and data that may inform future research. The company noted the kitted format is designed to streamline implementation, with integrated bioinformatics and customized support, and to reduce the validation burden compared with laboratory-developed tests, requiring only on-site verification steps.

The approval adds to Labcorp’s expanding precision medicine portfolio, which spans tissue- and liquid-based oncology diagnostics intended to support personalized cancer care, according to the release.

The FDA’s public premarket approval (PMA) database lists the device’s generic name as a “next generation sequencing oncology panel, somatic or germline variant detection system,” approved under PMA number P250036.⁴ The application, submitted by Personal Genome Diagnostics Inc., a Labcorp subsidiary based in Baltimore, Maryland, was received by the FDA on September 10, 2025, and the agency issued its decision on July 30, 2026. The device was assigned product code PQP and reviewed under the FDA’s Molecular Genetics advisory committee panel; expedited review was not granted.

With this approval, PGDx elio tissue complete CDx becomes an in-house testing option for hospitals and health systems seeking to identify BRAF-altered melanoma tumors without sending samples to an outside reference laboratory, potentially shortening the time between biopsy and treatment initiation for patients with this aggressive disease.

References

1. Labcorp announces FDA approval of companion diagnostic supporting patients with advanced melanoma. News release. Labcorp. August 10, 2026. Accessed August 11, 2026. https://tinyurl.com/yc9ea4ck
2. Survival rates for melanoma of the skin, by stage. SEER Training Modules. National Cancer Institute. Accessed August 11, 2026. https://tinyurl.com/46vxpw4s
3. PGDx elio® tissue complete CDx. Labcorp. Accessed August 11, 2026. https://tinyurl.com/arknmb32
4. Premarket approval (PMA): PGDx elio tissue complete CDx, P250036. U.S. Food and Drug Administration. Accessed August 11, 2026. https://tinyurl.com/3h4nzyfd