NeoGenomics Inc. said the U.S. Centers for Medicare & Medicaid Services (CMS) has expanded coverage for its RaDaR ST circulating tumor DNA test to include immunotherapy monitoring in patients with late-stage solid tumors.
The decision marks the third Medicare-covered indication for the test, which previously received coverage for HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive, HER2-negative breast cancer. Coverage is provided under the Plasma-Based Genomic Profiling in Solid Tumors policy.
The RaDaR ST test uses a tumor-informed approach, analyzing up to 48 patient-specific variants identified through whole-exome sequencing to detect circulating tumor DNA at low variant allele fractions. It supports three clinical uses: recurrence-risk assessment after surgery, recurrence monitoring during surveillance, and treatment-response monitoring during systemic therapy.
The expanded coverage comes as immunotherapy increasingly shapes treatment for solid tumors. In lung cancer, immunotherapy accounts for an estimated 55% of treated cases, while in melanoma, it represents about 70% of cases. Other solid tumors where immunotherapy is a standard treatment include bladder cancer and renal cell carcinoma.
NeoGenomics CEO Tony Zook said the coverage determination positions the company to advance the 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,' Zook said.
The company has two additional RaDaR ST submissions pending with MolDX, the CMS program overseeing molecular diagnostic services.
Shares of NeoGenomics closed at $17.37 on Aug. 24, up 3.45%, and were up 0.46% in after-hours trading on Aug. 26.
