FDA Grants Two New Breakthrough Device Designations for MRD Testing
Posted: Tuesday, April 6, 2021
On March 24, the U.S. Food and Drug Administration (FDA) granted two Breakthrough Device designations that would expand the uses of the Signatera molecular residual disease (MRD) test. Along with a Breakthrough Device designation in 2019, the new FDA announcement gives Singatera a total of three Breakthrough Device designations across multiple tumor types and indications including breast, bladder, colorectal, and non–small cell lung cancer. The two designations should support its testing in phase III clinical trials as a companion diagnostic to two different cancer therapies.
Signatera is a custom-built circulating tumor DNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. It provides patients with a customized blood test tailored to fit the unique signature of clonal mutations found in their tumor. This is intended to maximize accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood.