NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetics testing services and global oncology contract research services, is providing an update on its discussions with MolDX and on its commercial launch activities for RaDaRTM, its proprietary assay for the detection of minimal residual disease (MRD) and recurrence.
Late last week, MolDX informed the Company that additional clinical evidence is needed to secure Medicare coverage for RaDaRTM for Colorectal Cancer (CRC). Specifically, MolDX asked for a direct comparison with other MRD tests being utilized or a full clinical study. Therefore, due to the strength of published clinical data, the Company will prioritize commercial and reimbursement efforts in breast cancer, with an accelerated commercial launch of RaDaRTM for breast cancer targeted for Q1, 2023. Clinical data supporting the use of RaDaRTM in early-stage breast cancer have been presented in both published papers and through presentations at professional meetings. In addition, NeoGenomics will launch RaDaRTM for CRC in the first quarter, while also expanding clinical research studies to support reimbursement from Medicare and other payors.
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