The expansion allows for longitudinal molecular testing to track treatment response in patients with late-stage solid tumors.
NeoGenomics announced that its RaDaR ST molecular residual disease (MRD) assay received expanded coverage from the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostic Services Program. The new coverage includes immunotherapy monitoring for patients with late-stage solid tumors.
Medicare coverage for the assay now includes the monitoring of response to immune-checkpoint inhibitor therapy. This represents the third Medicare-covered indication for RaDaR ST, which is also indicated for HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive, HER2-negative breast cancer. The company currently has two additional submissions pending with the program.
Addressing Limitations in Imaging
Immunotherapy is a standard treatment for several common solid tumors, including lung cancer, melanoma, bladder cancer, and renal cell carcinoma. However, traditional imaging often cannot reliably distinguish true treatment response from early inflammatory changes, which can complicate clinical decisions regarding whether to continue or adjust therapy.
Longitudinal molecular testing throughout the course of treatment may help identify early signs of progression that might otherwise be missed. It can also clarify response in the context of pseudoprogression, which is inflammation present on imaging that can occur during treatment with immunotherapy.
“As immunotherapy continues to reshape solid tumor treatment, clinicians want more dynamic tools to evaluate how patients are responding over time,” says Tony Zook, CEO of NeoGenomics, in a release. “Personalized MRD testing delivers longitudinal molecular insights that complement traditional assessment methods throughout the patient’s treatment journey.”
Assay Performance and Methodology
The RaDaR ST assay utilizes a tumor-informed approach, analyzing up to 48 patient-specific variants identified through whole-exome sequencing to detect circulating tumor DNA (ctDNA) at a low variant allele fraction. The assay supports three core clinical uses: recurrence-risk assessment after curative-intent surgery, recurrence monitoring during surveillance, and longitudinal treatment-response monitoring during systemic therapy.
Studies across multiple solid tumor types have demonstrated that the assay can detect ctDNA as low as 1 part per million. Evidence for the assay in the immunotherapy setting has been shown in studies involving melanoma, head and neck, breast, and bladder cancers.
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