NeoGenomics, Inc. (NASDAQ: NEO) announced that its RaDaR ST molecular residual disease (MRD) assay has received expanded Medicare coverage from the Centers for Medicare & Medicaid Services' Molecular Diagnostic Services Program to include immunotherapy response monitoring in patients with late-stage solid tumors.

This marks the third Medicare-covered indication for RaDaR ST. The test was previously covered for HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive, HER2-negative breast cancer. NeoGenomics said it has two additional RaDaR ST submissions pending with the program.

The new coverage applies to monitoring of response to immune-checkpoint inhibitor therapy in patients with late-stage solid tumors. Immunotherapy is a standard treatment for several common cancers, including lung cancer, melanoma, bladder cancer, and renal cell carcinoma. According to internal data cited by the company, immunotherapy accounts for an estimated 55% of treated lung cancer cases and 70% of melanoma cases.

RaDaR ST uses a tumor-informed approach, analyzing up to 48 patient-specific variants identified through whole-exome sequencing to detect circulating tumor DNA at a variant allele fraction as low as one part per million. The assay supports recurrence-risk assessment after surgery, recurrence monitoring during surveillance, and treatment-response monitoring during systemic therapy.

"As immunotherapy continues to reshape solid tumor treatment, clinicians want more dynamic tools to evaluate how patients are responding over time," said Tony Zook, CEO of NeoGenomics. "This coverage marks a critical milestone in expanding access to RaDaR ST in a large and growing indication."

NeoGenomics is headquartered in Fort Myers, Florida, and operates a network of CAP-accredited and CLIA-certified laboratories across the United States, as well as a laboratory in Cambridge, England.