NeoGenomics’ Newly Published Study Underscores Potential of ctDNA as a Predictive Tool for Monitoring Patients with High-Risk Melanoma

NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, announced the recent publication of a new study in ESMO Open, demonstrating how circulating tumor DNA (ctDNA) in monitoring molecular residual disease (MRD) may enable earlier identification of disease recurrence for high-risk melanoma patients.

Melanoma impacted over 100,000 patients in 2023; the majority (55%) were men. Locally advanced melanoma is a complex disease with a risk of relapse ranging from 39% in stage IIIA to approximately 70% in stage IIIC. The study, “Bespoke ctDNA for Longitudinal Detection of Molecular Residual Disease in High-Risk Melanoma Patients,” was conducted alongside researchers from the Princess Margaret Hospital at the University of Toronto and assessed ctDNA in 276 plasma samples from 66 melanoma patients. Utilizing RaDaR^®, NeoGenomics’ next-generation sequencing assay, researchers found that ctDNA detection after surgery can identify patients with worse prognosis, and serial ctDNA measurements may enable earlier identification of disease recurrence.

Many earlier ctDNA studies in melanoma utilized technologies that target a narrow spectrum of recurrent driver alterations, an approach that limits application in patients with tumors lacking BRAF and NRAS mutations. In contrast, the study successfully identified ctDNA in patients with tumors lacking BRAF and NRAS mutations, suggesting that this tumor-informed approach may be informative in a wider range of patients.

“There is an urgent need for dependable biomarkers to define recurrence risk and identify melanoma patients who would benefit most from adjuvant treatment, as no reliable criteria currently exist to guide therapy selection,” said Warren Stone, Chief Commercial Officer at NeoGenomics. “This study highlights the value of ctDNA in addressing this gap and provides a foundation for future research and integration into routine clinical care, aiming to improve patient outcomes.”

This study is an example of the potential applications of ctDNA for the implementation of novel therapeutic strategies aimed at improving the care of cancer patients, and findings have led to the development of the CLEAR-Me trial, an interception study to detect and clear MRD in patients with high-risk melanoma (NCT06319196).

About NeoGenomics, Inc.

NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom.

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