NEW YORK – NeoGenomics announced on Tuesday that its RaDaR liquid biopsy test for minimal residual disease detection and cancer recurrence has received CE marking.
The firm also said in a statement that its subsidiary Inivata, which developed the test, has submitted the assay to the Centers for Medicare and Medicaid's MolDx program in the US for reimbursement coverage. Both the CE mark and MolDx submission will support the commercialization of RaDaR in a clinical setting in collaboration with biopharma and other partners and in Inivata's own clinical development program, NeoGenomics said.
RaDaR, which stands for "residual disease and recurrence," tracks a set of up to 48 tumor specific variants in a patient, which allows for both the detection of residual disease following curative intent or definitive treatment and early detection of relapse, NeoGenomics said. In previous analytic data, the test demonstrated 95 percent sensitivity and 100 percent specificity at circulating tumor DNA concentration levels as low as 11 parts per million, the company added.
The CE marking "should strengthen both our ability to support clinical trials in Europe and the future commercialization of the MRD assay," Inivata President Clive Morris said in a statement. "In the US, submitting to the MolDx program for the reimbursement of RaDaR represents our continuing efforts to accelerate access to our vital technology."
The test received breakthrough device designation from the US Food and Drug Administration in March and has been offered as a laboratory-developed test at Inivata's lab in North Carolina since late 2020.