Cell-free DNA testing company Natera Inc (NASDAQ: NTRA) said on Monday that it has submitted a premarket approval application to the US Food and Drug Administration (FDA) for Signatera CDx to detect molecular residual disease (MRD) in patients with muscle-invasive bladder cancer who may benefit from treatment with atezolizumab (Tecentriq).

The submission is supported by data from the randomised, double-blind phase 3 IMvigor011 trial, which met its primary endpoint and validated MRD-guided therapy in this patient population. In the study, Signatera-positive patients treated with atezolizumab showed statistically significant and clinically meaningful improvements in disease-free and overall survival compared with placebo, while Signatera-negative patients demonstrated a low risk of recurrence without adjuvant immunotherapy.

Trial results were presented at a Presidential Symposium at the European Society for Medical Oncology Congress in October 2025 and published concurrently in The New England Journal of Medicine.

Bladder cancer is the sixth most common cancer in the United States, with muscle-invasive disease accounting for 20-25% of new diagnoses.

The IMvigor011 trial, sponsored by Genentech, was designed to address the challenge of identifying patients at high risk of recurrence following curative-intent surgery and tailoring treatment accordingly.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY).