Natera has submitted its Signatera molecular residual disease test to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing is supported by data from IMvigor011, a double-blind Phase III trial in patients who were ctDNA-positive post-cystectomy but had no radiographic disease. In IMvigor011, patients receiving Tecentriq had disease-free survival nearly double that of the placebo arm, with median overall survival also longer. Earlier this year, PMDA approved Signatera for colorectal cancer, making the bladder application a direct expansion of Japan’s first-approved MRD footprint. Strategically, the submission signals accelerating MRD adoption for oncology decision-making beyond the US, positioning ctDNA-guided strategies as a route to tighter post-surgical risk stratification internationally.