NeoGenomics Receives Medicare Coverage for RaDaR ST MRD Assay in Immunotherapy Monitoring
核心洞察
NeoGenomics' RaDaR ST (搜索) molecular residual disease (MRD) assay received expanded Medicare coverage from CMS's MolDX program for monitoring response to immune-checkpoint inhibitor therapy in late-stage solid tumors.
This marks the third Medicare-covered indication for RaDaR ST (搜索), joining HPV-negative head and neck squamous cell carcinoma (搜索) and a subset of HR+/HER2-negative breast cancer (搜索).
Immunotherapy accounts for an estimated 55% and 70% of treated lung cancer (搜索) and melanoma (搜索) cases, respectively, underscoring the need for tools that distinguish true response from pseudoprogression.
NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions enabling precision medicine, announced that its RaDaR ST (搜索) 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. The coverage determination, announced August 26, 2026, marks the third Medicare-covered indication for the assay.
Medicare coverage for RaDaR ST (搜索) now includes monitoring of response to immune-checkpoint inhibitor therapy in patients with late-stage solid tumors. The assay's two prior covered indications are HPV-negative head and neck squamous cell carcinoma (搜索) and a subset of hormone receptor-positive (HR+), HER2-negative breast cancer (搜索). NeoGenomics also has two additional RaDaR ST submissions pending with MolDX.
Addressing a Gap in Immunotherapy Response Assessment
Immunotherapy is now standard treatment across numerous common solid tumors, including lung cancer (搜索), melanoma (搜索), bladder cancer (搜索), and renal cell carcinoma (搜索), 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 during immunotherapy. In lung cancer (搜索) and melanoma (搜索) 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.
Clinical Evidence Across Solid Tumor Types
Evidence for RaDaR ST (搜索) in the immunotherapy setting has been demonstrated across multiple studies, including melanoma (搜索), head and neck, breast, and bladder cancers. In advanced head and neck cancer treated with immune checkpoint blockade, circulating tumor DNA (ctDNA) dynamics tracked with survival and response to treatment.
"We view this coverage determination as a cornerstone of our launch of RaDaR ST (搜索)," 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."
Technology and Clinical Applications
RaDaR ST (搜索) 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 1 ppm.
NeoGenomics, headquartered in Fort Myers, FL, operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US, as well as a CAP-accredited full-service sample-processing laboratory in Cambridge, England.