Tumor-Informed MRD Assay Gains Medicare Coverage for Immunotherapy Monitoring

This marks the assay’s third Medicare-covered indication, following coverage for human papillomavirus (HPV)-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Coverage is provided under the MolDX Local Coverage Determination, Plasma-Based Genomic Profiling in Solid Tumors (L38043), while two additional RaDaR ST submissions remain pending with MolDX.

RaDaR ST uses a tumor-informed approach that identifies up to 48 patient-specific variants through whole-exome sequencing and tracks those variants in plasma to detect circulating tumor DNA (ctDNA) at very low variant allele fractions (VAFs). The assay is designed to support recurrence-risk assessment after curative-intent surgery, recurrence monitoring during surveillance, and longitudinal treatment-response monitoring during systemic therapy. Under study-specific conditions, RaDaR ST has demonstrated detection down to 1 part per million, with a 95% limit of detection of 11 parts per million.

Evidence supporting RaDaR ST in the immunotherapy setting spans melanoma, head and neck, breast, and bladder cancers, with ctDNA dynamics shown to correlate with survival and treatment response in advanced head and neck cancer treated with immune checkpoint blockade. As immunotherapy becomes standard across multiple common solid tumors and may continue for years, imaging alone can be insufficient to distinguish early response from pseudoprogression. In lung cancer and melanoma, immunotherapy accounts for an estimated 55% and 70% of treated cases, respectively, underscoring the potential value of longitudinal molecular monitoring.

NeoGenomics highlights the determination as expanding access to MRD testing across the cancer care continuum, including treatment‑response monitoring for patients on immunotherapy. The expanded coverage is effective for patients with late‑stage solid tumors treated with immune‑checkpoint inhibitors.

“We view this coverage determination as a cornerstone of our launch of RaDaR ST. 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,” said Tony Zook, CEO of NeoGenomics.

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