Natera submitted its Signatera molecular residual disease test to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The application is supported by data from the IMvigor011 Phase 3 trial, which randomized ctDNA-positive post-cystectomy patients to Tecentriq (atezolizumab) versus placebo. Natera said disease-free survival nearly doubled in the Tecentriq arm compared with placebo, with median overall survival also longer on active treatment. The company also noted that Signatera MRD has already received FDA companion-diagnostic approval for adjuvant Tecentriq and that Japan has approved Signatera for colorectal cancer earlier this year. This move extends MRD expansion beyond oncology treatment decisions to the regulatory CDx pathway in additional geographies.