Natera submits premarket approval to FDA for Signatera CDx

Natera (NTRA) announced the submission of its premarket approval, or PMA, to the FDA for Signatera CDx for detection of molecular residual disease, or MRD, in patients with muscle-invasive bladder cancer, or MIBC, who may benefit from treatment with atezolizumab, or Tecentriq. This submission is supported by data from the randomized, double-blind, phase 3 IMvigor011 clinical trial, which met its primary endpoint and demonstrated the benefits of Signatera-guided therapy in MIBC. In the study, Signatera-positive patients treated with atezolizumab had statistically significant and clinically meaningful improvements in disease-free survival and overall survival, compared with placebo. The trial also showed that Signatera-negative patients had a low risk of recurrence without adjuvant immunotherapy. Results were featured in a Presidential Symposium at the European Society for Medical Oncology Congress on October 20, 2025, with a concurrent publication in The New England Journal of Medicine. Bladder cancer is the sixth most common cancer in the U.S. and MIBC represents 20%-25% of the newly diagnosed cases.