Signatera CDx approved by FDA as companion diagnostic in MIBC

Natera (NTRA) announced that the U.S. Food and Drug Administration has approved Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab 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. Signatera CDx has been approved by the FDA for use with adjuvant atezolizumab to identify patients with MIBC who are ctDNA MRD-positive and may benefit from treatment,” the company stated.