Fort Myers, Fla. — NeoGenomics, Inc. said its RaDaR ST molecular residual disease assay has received expanded Medicare coverage for monitoring immunotherapy response in patients with late-stage solid tumors.
The coverage was granted through the Centers for Medicare & Medicaid Services’ Molecular Diagnostic Services Program, or MolDX, and applies to patients receiving immune checkpoint inhibitor therapy.
The new indication is the third Medicare-covered use for RaDaR ST. The test is also covered for HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive, HER2-negative breast cancer. NeoGenomics said two additional RaDaR ST submissions are pending with MolDX.
Immunotherapy is widely used to treat solid tumors including lung cancer, melanoma, bladder cancer and renal cell carcinoma. However, imaging can sometimes have difficulty distinguishing actual disease progression from treatment-related inflammation, known as pseudoprogression.
NeoGenomics said longitudinal molecular testing may help clinicians identify early signs of progression and better evaluate treatment response over time.
“We view this coverage determination as a cornerstone of our launch of RaDaR ST,” said Tony Zook, CEO of NeoGenomics. “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,” Zook said. “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.”
RaDaR ST uses a tumor-informed approach that analyzes up to 48 patient-specific genetic variants identified through whole-exome sequencing to detect circulating tumor DNA, or ctDNA, at very low levels.
The assay is designed for three primary clinical uses: assessing recurrence risk after curative-intent surgery, monitoring for recurrence during surveillance and tracking treatment response during systemic therapy.
NeoGenomics said RaDaR ST has been evaluated in published studies involving several solid tumor types, including melanoma, head and neck, breast and bladder cancers.
