Benzinga | Mar 24, 2021 09:04AM EDT

FDA Grants Two New Breakthrough Device Designations For Natera's Signatera MRD Test

Natera, Inc. (NASDAQ:NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the US Food and Drug Administration (FDA) has granted two Breakthrough Device Designations (BDDs) covering new intended uses of the Signatera molecular residual disease (MRD) test. These new designations will support the development of Signatera through Phase III clinical trials as a companion diagnostic to two different cancer therapies. Together with the BDD granted to Signatera in 2019, this makes a total of three BDDs granted across multiple cancer types and indications.