Fort Myers, Florida – August 26, 2026
NeoGenomics announced that its RaDaR ST molecular residual disease (MRD) assay has received expanded Medicare coverage through the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostic Services Program (MolDX) for immunotherapy treatment-response monitoring in patients with late-stage solid tumors. The coverage expands the clinical use of RaDaR ST into an important area of cancer care, where physicians increasingly need tools that can provide molecular information alongside conventional imaging. The Medicare decision represents the third covered indication for RaDaR ST, following coverage for HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive, HER2-negative breast cancer. The expanded indication specifically includes monitoring response to immune-checkpoint inhibitor therapy in patients with advanced solid tumors. As immunotherapy becomes an established treatment approach across cancers including lung cancer, melanoma, bladder cancer and renal cell carcinoma, NeoGenomics is positioning RaDaR ST as a tool for longitudinal molecular assessment during treatment. The reimbursement decision is therefore an important development for the company’s oncology diagnostics portfolio and precision-medicine strategy.
RaDaR ST Adds Molecular Insight to Immunotherapy Monitoring
RaDaR ST is a tumor-informed MRD assay designed to track circulating tumor DNA (ctDNA) over time. The assay analyzes up to 48 patient-specific genetic variants identified through whole-exome sequencing and is designed to detect ctDNA at very low variant allele fractions. NeoGenomics states that RaDaR ST can support three principal clinical applications: assessing recurrence risk following curative-intent surgery, monitoring recurrence during surveillance and evaluating treatment response during systemic therapy. The newly expanded Medicare coverage specifically addresses the latter application in patients receiving immunotherapy. Conventional imaging remains a central component of treatment assessment, but inflammatory changes associated with immune-checkpoint inhibitors can sometimes make radiologic findings difficult to interpret. Pseudoprogression, in which inflammation can resemble tumor growth on imaging, is one example of the challenge clinicians may face during immunotherapy. Longitudinal ctDNA testing is being explored as a complementary source of molecular information that could help characterize whether disease is responding or progressing. NeoGenomics said evidence supporting RaDaR ST in immunotherapy settings has been generated across multiple cancer types, including melanoma, head and neck, breast and bladder cancers.
Medicare Expansion Broadens RaDaR ST Clinical Reach
The new coverage expands the population that can potentially access RaDaR ST through Medicare and represents a significant reimbursement milestone for NeoGenomics. The company said immunotherapy is now used across numerous common solid tumors and can continue for extended treatment periods, creating demand for tools capable of monitoring patients throughout therapy. NeoGenomics highlighted the potential importance of molecular monitoring in cancers such as lung cancer and melanoma, where immune-checkpoint inhibitor treatment represents a substantial portion of treated cases. In advanced head and neck cancer, the company cited evidence showing that ctDNA dynamics were associated with survival and treatment response during immune-checkpoint blockade. While these findings support further use of molecular response monitoring, the coverage decision itself should not be interpreted as proof that RaDaR ST improves patient outcomes or replaces imaging. Instead, the assay is intended to provide additional molecular information that may complement traditional clinical and radiologic assessments. NeoGenomics also has two additional RaDaR ST submissions pending with MolDX, potentially creating further opportunities for reimbursement expansion.
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NeoGenomics Advances Precision Cancer Diagnostics
The Medicare decision strengthens NeoGenomics’ position in molecular oncology diagnostics by expanding RaDaR ST across multiple points in the cancer care continuum. The assay’s tumor-informed design is intended to provide personalized ctDNA monitoring based on molecular characteristics identified from each patient’s tumor. NeoGenomics reports detection capability as low as 1 part per million (1ppm) and says the assay has demonstrated analytical and clinical performance across multiple solid tumor types in published studies. With immunotherapy increasingly integrated into treatment strategies for advanced cancer, the ability to follow molecular changes over time is becoming an important area of diagnostic development. The expanded Medicare coverage provides a pathway for broader clinical adoption of RaDaR ST in eligible patients receiving immune-checkpoint inhibitor therapy. For NeoGenomics, the development also supports the company’s broader strategy of delivering precision oncology diagnostics that generate actionable molecular information throughout cancer treatment. Further reimbursement decisions and continued clinical evidence will be important in determining the longer-term adoption and commercial impact of RaDaR ST.
Source:NeoGenomics press relese
