Liquid Biopsies Dominate FDA’s Latest Breakthrough Device Nods
May 10, 2021Liquid biopsy developers feature heavily in the latest round of FDA breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status for their blood-based cancer tests.
Natera disclosed two breakthrough designations for its Signatera molecular residual disease (MRD) test. The designations provide a boost to Natera’s efforts to develop the circulating tumor DNA test through phase 3 trials as a companion diagnostic to two cancer medicines.