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
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
