WASHINGTON (dpa-AFX) - Natera, Inc. (NTRA), a cell-free DNA and precision medicine company, announced Friday 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 screen for multiple cancers. In granting the BDD, the FDA assessed data from 12 cancer types and considered sensitivity, specificity, and cancer signal origin (CSO) performance. The test generated compelling results to support the designation.
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