NeoGenomics, Inc. announced expanded Medicare coverage for its RaDaR ST molecular residual disease (MRD) testing. The decision supports immunotherapy treatment response monitoring in patients with late stage solid tumors . The Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has extended the coverage of the RaDaR ST molecular residual disease assay. Now the coverage includes monitoring for patients with advanced solid tumors receiving immunotherapy.
As a result, Medicare will cover RaDaR ST for monitoring responses to immune-checkpoint inhibitor therapy. This marks the third Medicare-covered indication for the assay. Previously, coverage included HPV-negative head and neck squamous cell carcinoma. It also covered a subset of hormone receptor-positive (HR+), HER2-negative breast cancer. Meanwhile, NeoGenomics has submitted two additional RaDaR ST indications to MolDX. Those submissions remain under review.
Expanding Monitoring During Immunotherapy Treatment
Immunotherapy is now standard treatment for several major solid tumors. The cancers are lung cancer, melanoma, bladder cancer and kidney cancer. Patients may also receive immunotherapy for extended periods of time. Clinicians need reliable tools to assess treatment response over time. The imaging methods that are used in immunotherapy treatments can be hard to do. In some cases, scans do not reliably distinguish between treatment response and inflammatory changes.
These changes can make it hard to determine whether to continue or change therapy or stop it. Thus, serial molecular testing may add information during therapy. RaDaR ST could be used to detect early molecular signs of disease progression. If imaging shows pseudoprogression, it can also provide context. Pseudoprogression is the inflammation seen on imaging in the setting of immunotherapy. Thus, molecular monitoring may aid clinicians in interpreting these complicated treatment responses.
There is still a large potential reach across major cancer types. Immunotherapy comprises around 55% of treated lung cancer cases. Immunotherapy represents around 70% of treated cases in melanoma. These data illustrate the need for better monitoring of response to treatment.
RaDaR ST Clinical Data
The RaDaR ST has been studied in immunotherapy settings in a number of studies. The study looked at melanoma, head and neck, breast and bladder cancers. Researchers have observed meaningful ctDNA patterns in advanced head and neck cancer. These signatures were linked to survival and response to immune checkpoint blockade therapy.
Tony Zook, CEO of NeoGenomics, highlighted the importance of the new coverage decision.
“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 Uses Tumor-Informed Molecular Testing
RaDaR ST uses a tumor-informed approach to analyze patient-specific genetic variants. The assay can evaluate up to 48 variants identified through whole-exome sequencing. This approach helps detect circulating tumor DNA (ctDNA) at a very low variant allele fraction (VAF). As a result, the technology supports sensitive molecular monitoring across different treatment stages.
RaDaR ST supports three primary clinical applications. First, it helps assess recurrence risk following curative-intent surgery. Second, the assay supports recurrence monitoring during surveillance. Third, it enables longitudinal treatment-response monitoring during systemic therapy. Furthermore, published studies have evaluated RaDaR ST across multiple solid tumor types. These studies have reported strong analytical and clinical performance.
The detection limit of this assay has been found to be 1ppm. Expanded Medicare coverage could thus mean increased access to MRD testing for those with cancer who are eligible. Recent decision strengthens NeoGenomics position in oncology diagnostics. It supports the company’s focus on precision medicine and advanced cancer monitoring.
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News Source: Businesswire.com
