Natera submitted a premarket approval (PMA) application for its Signatera CDx assay to the U.S. Food and Drug Administration as a companion diagnostic to guide adjuvant treatment decisions with Genentech’s Tecentriq (atezolizumab) in muscle‑invasive bladder cancer. The submission rests on randomized Phase 3 IMvigor011 data showing Signatera‑positive patients derived statistically significant disease‑free and overall survival benefits with adjuvant immunotherapy. Natera said Signatera‑negative patients showed low recurrence risk without adjuvant immunotherapy. The company positioned the filing as a step toward making minimal residual disease (MRD)‑guided treatment decisions routine; MRD testing detects trace tumor DNA after curative‑intent therapy to forecast recurrence risk.