Natera has submitted Signatera MRD to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing supports use of the ctDNA test to guide post-cystectomy treatment decisions for Tecentriq (atezolizumab) versus placebo in patients who are Signatera-positive. Natera said the application is backed by IMvigor011, a double-blind Phase III trial in which disease-free survival was nearly doubled in the Tecentriq arm. Median overall survival also favored immunotherapy, with survival at two years higher in the treatment group. Japan has already approved Signatera for colorectal cancer, and Natera is positioning its bladder-cancer submission as part of a broader MRD footprint tied to checkpoint inhibitor benefit. If approved, the Japan rollout could expand MRD-guided oncology care for patients selected by ctDNA status.