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

By: via Business Wire

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.

Forward-Looking Statements

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “plan,” “potential” and other words of similar meaning, although not all forward-looking statements include these words. This press release includes forward-looking statements. These forward-looking statements address various matters, including statements regarding improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the Company's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, to continue gaining new customers, offer new types of tests, integrate its acquisitions and otherwise implement its business plan, and the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and the Company's other filings with the Securities and Exchange Commission.

We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

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