Posted by Michael Wonder on 24 Mar 2021
FDA grants two new breakthrough device designations for Natera’s Signatera MRD test
24 March 2021 - Natera today announced that the US FDA has granted two breakthrough device designations covering new intended uses of the Signatera molecular residual disease test.
These new designations will support the development of Signatera through Phase 3 clinical trials as a companion diagnostic to two different cancer therapies.
Together with the breakthrough therapy designation granted to Signatera in 2019, this makes a total of three breakthrough device designations granted across multiple cancer types and indications.
