NEW YORK – NeoGenomics said Thursday that its minimal residual disease assay Radar is now covered by the Centers for Medicare & Medicaid Services for cancer recurrence detection and monitoring in patients with breast cancer after the firm passed the required MolDx technical assessment.
Medicare administrative contractor Palmetto, which oversees the MolDx program, issued a local coverage determination in 2021 authorizing coverage for MRD tests as long as tests are deemed appropriate by MolDx.
NeoGenomics said that Radar tests are now covered for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, including those with a personal history of high-risk stage II/III HR+/HER2- breast cancer, five or more years from diagnosis, who presently do not have evidence of disease. Coverage is backdated to March 24 of this year.
Like other leading technologies, the firm's MRD assays are patient-specific, with a blood test designed for each individual using targets gleaned from initial sequencing of their tumor tissue. Its competitor Natera, which employs a similar approach, also gained Medicare coverage for MRD testing in breast cancer this February.
NeoGenomics had initially struggled to obtain coverage from Medicare, failing in its bid to the MolDx program for a colorectal cancer indication in 2022. The company has previously said that it planned to submit at least two other indications aside from breast cancer for technical assessments by the end of this year.