NeoGenomics Receives Medicare Coverage for RaDaR ST for Immunotherapy Treatment Response Monitoring

New coverage extends RaDaR ST to patients with advanced cancer on immunotherapy, expanding MRD testing across the cancer care continuum

FORT MYERS, Fla.--(BUSINESS WIRE)--NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, announced that its RaDaR^® ST molecular residual disease (MRD) assay has received expanded coverage from the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) to include immunotherapy monitoring for patients with late-stage solid tumors.

Medicare coverage for RaDaR ST now includes monitoring of response to immune-checkpoint inhibitor therapy in patients with late-stage solid tumors.¹ This is the third Medicare-covered indication for RaDaR ST, which also includes HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive (HR+), HER2-negative breast cancer. NeoGenomics also has two additional RaDaR ST submissions pending with MolDX.

Immunotherapy is now standard treatment across numerous common solid tumors, including lung cancer, melanoma, bladder cancer, and renal cell carcinoma, often continuing for years. However, imaging alone often cannot reliably distinguish true response from early treatment-related inflammatory changes, complicating decisions about whether to continue, adjust, or stop therapy. Longitudinal molecular testing over the course of treatment may help identify early signs of progression that might otherwise be missed and clarify response in the context of pseudoprogression (inflammation present on imaging) that can occur in treatment with immunotherapy. In lung cancer and melanoma alone, immunotherapy accounts for an estimated 55% and 70% of treated cases, respectively, underscoring how many patients could benefit from better tools to track how they are responding.²

Evidence for RaDaR ST in the immunotherapy setting has been demonstrated across multiple studies, including melanoma, head and neck, breast, and bladder cancers.^3-6 In advanced head and neck cancer treated with immune checkpoint blockade, ctDNA dynamics tracked with survival and response to treatment.⁶

“We view this coverage determination as a cornerstone of our launch of RaDaR ST,” said Tony Zook, CEO of NeoGenomics. “As immunotherapy continues to reshape solid tumor treatment, clinicians want more dynamic tools to evaluate how patients are responding over time. Personalized MRD testing delivers longitudinal molecular insights that complement traditional assessment methods throughout the patient's treatment journey. This coverage marks a critical milestone in expanding access to RaDaR ST in a large and growing indication, and we continue to anticipate further reimbursement decisions to support growth in the coming years.”

RaDaR ST employs a tumor-informed approach, analyzing up to 48 patient-specific variants identified through whole-exome sequencing to detect ctDNA at a very low variant allele fraction (VAF). It supports three core clinical uses: recurrence-risk assessment after curative-intent surgery, recurrence monitoring during surveillance, and longitudinal treatment-response monitoring during systemic therapy. Across these settings, RaDaR ST has demonstrated strong analytical and clinical performance in numerous published studies spanning multiple solid tumor types with detection as low as 1ppm.⁷

About NeoGenomics

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, providing oncologists, pathologists, hospital systems, academic medical centers, and pharmaceutical firms with innovative diagnostic and predictive testing to deliver timely, actionable insights that guide personalized care decisions. 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, England.

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,” “can,” “guide”, “could,” “want,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “potential” and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements address various matters, including statements regarding the Company’s strategy, planned future operations and development plans and initiatives, the potential of RaDaR ST to support therapy selection and longitudinal disease monitoring in patients with advanced solid tumors; the Company’s expectations regarding the correlation between the availability of Medicare coverage and the ability of physicians to deliver timely, personalized treatment strategies for their patients; and the potential impact of Medicare coverage and potential future coverage to support wider clinical adoption of RaDaR ST. 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 statements. Applicable risks and uncertainties include, among others, risks with respect to the Company’s ability to maintain Medicare coverage for its products and the market acceptance of its products, as well as 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 and in the “Investors” section of our website at ir.neogenomics.com, 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.

References

1. Coverage is provided under LCD - MolDX: Plasma-Based Genomic Profiling in Solid Tumors (L38043).
2. Internal TAM market data on file.
3. Weber JS, Carlino MS, Khattak A, et al. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024;403(10427):632-644.
4. Lynce F, Mainor C, Donahue RN, et al. Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study. Nat Commun. 2024;15(1):2691.
5. van Dorp J, Pipinikas C, Suelmann BBM, et al. High- or low-dose preoperative ipilimumab plus nivolumab in stage III urothelial cancer: the phase 1B NABUCCO trial. Nat Med. 2023;29(3):588-592.
6. Ruiz-Torres DA, Merkin RD, Bryan ME, et al. Personalized circulating tumor DNA dynamics inform survival and response to immune checkpoint blockade in recurrent/metastatic head and neck cancer. NPJ Precis Oncol. 2025;9(1):298.
7. Limit of detection with 95% probability (LOD95) at 11 ppm; detection down to 1 part per million under study specific conditions (NeoGenomics data on file).