NeoGenomics, an oncology testing services company, announced that the Molecular Diagnostics Services Program (MolDx) has conveyed coverage for the RaDaR assay, a personalized liquid biopsy for minimal residual disease (MRD) and recurrence detection.
Following this decision, effective as of March 24, 2023, the RaDaR assay is now covered for fee-for-service Medicare patients within the United States with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, according to the company. The coverage includes patients 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.
NeoGenomics’ tumor informed RaDaR assay has been designed to detect extremely low levels of circulating tumor DNA (ctDNA) in the blood with exceptional sensitivity and specificity. RaDaR can monitor up to 48 tumor-specific variants unique to each patient’s tumor, giving patients additional time and information for important treatment management decisions.
“Gaining our first Medicare coverage decision from MolDx for breast cancer is a significant milestone for the company, the clinicians we partner with, and the patients we serve,” says Chris Smith, CEO of NeoGenomics. “RaDaR, our MRD technology, addresses an unmet clinical need and improves clinicians’ ability to accurately predict the risk of cancer recurrence.”