Diagnostics reimbursement and platform expansion – MRD testing gains CMS coverage for immunotherapy monitoring

NeoGenomics announced expanded Centers for Medicare and Medicaid Services (CMS) Molecular Diagnostic Services Program (MolDX) coverage for its tumor-informed MRD assay RaDar ST, adding immunotherapy response monitoring for late-stage solid tumors. The test uses whole-exome sequencing to analyze patient-specific circulating tumor DNA variants, building on prior MolDX coverage for recurrence risk after surgery and select recurrence monitoring indications. RaDar ST is positioned to complement imaging by providing longitudinal molecular insights during systemic therapy, particularly in settings where radiographic response may not fully capture changes in viable tumor dynamics. NeoGenomics said additional MolDX submissions are pending to broaden coverage further. The decision is commercially meaningful for MRD-based monitoring vendors, as coverage expansion can translate into broader adoption and faster scaling of reimbursement pathways for personalized oncology diagnostics.