NeoGenomics Inc. said the U.S. Centers for Medicare & Medicaid Services has expanded coverage for its RaDaR ST molecular residual disease assay under the Plasma-Based Genomic Profiling in Solid Tumors policy.
The expanded reimbursement allows Medicare to cover immunotherapy monitoring for patients with late-stage solid tumors, including lung cancer and melanoma, where immunotherapy accounts for an estimated 55% and 70% of treated cases, respectively. The assay analyzes up to 48 patient-specific variants identified through whole-exome sequencing to support clinical decision-making.
This marks the third Medicare-covered indication for RaDaR ST, following prior coverage for HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive, HER2-negative breast cancer. The company has two additional submissions pending with CMS’s Molecular Diagnostic Services Program (MolDX).
Tony Zook, NeoGenomics’ chief executive officer, said the coverage determination represents a key milestone for the RaDaR ST launch. He added that as immunotherapy reshapes solid tumor treatment, clinicians increasingly seek dynamic tools to assess patient responses over time. The test is used for recurrence-risk assessment after surgery, recurrence monitoring during surveillance, and treatment-response evaluation during systemic therapy.
