Natera submitted its Signatera molecular residual disease (MRD) test to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing is backed by IMvigor011, a double-blind Phase III trial in ctDNA-positive post-cystectomy patients, where Tecentriq-treated participants showed nearly double disease-free survival versus placebo. Natera’s push also positions Signatera within Japan’s expanding MRD category: the company said PMDA previously approved Signatera for colorectal cancer, making the device part of a precedent-setting regulatory pathway for molecular-guided adjuvant therapy decisions.