Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq®) immunotherapy in MIBC.

This is the first companion diagnostic approval in the field of blood-based MRD. It is a significant milestone in the industry-wide shift toward personalized, MRD-guided cancer care, in which treatment decisions may depend on Signatera™ MRD status, and interventions may be delayed or deferred for patients who remain MRD-negative. Supported by more than 185 peer-reviewed publications and Medicare coverage across multiple cancer types (including Bladder, Breast, Lung, Colorectal, Ovarian, and pan-cancer immunotherapy monitoring), Signatera has become a cornerstone of precision oncology.