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FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay
BusinessWire ·
BusinessWire reports: Natera, Inc. ( ), a global leader in cell-free DNA and precision medicine, today announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by the U.S. Food and Drug Administration (FDA). The BDD is designed for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. Natera’s MCED assay analyzes cell-free DNA in the blood to…