The submission advances Natera’s growing presence in Japan, where Signatera received PMDA approval in colorectal cancer in June, becoming the country’s first PMDA-approved molecular residual disease (MRD) test.

The MIBC application is supported by data from IMvigor011, a randomized, double-blind Phase 3 clinical trial. It also builds on recent milestones for Signatera in MIBC: the U.S. FDA’s approval of Signatera™ CDx as a companion diagnostic for adjuvant atezolizumab (Tecentriq®); and a Category 1 recommendation for Signatera MRD-guided adjuvant atezolizumab in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for Bladder Cancer.

Bladder cancer affects more than 34,000 people in Japan each year.1 Globally, approximately 20–25% of newly diagnosed bladder cancers are muscle-invasive.2 MIBC is a more aggressive form of the disease, associated with higher recurrence risk and treatment complexity.

"Signatera is a proven tool in bladder cancer management, and this submission reflects our commitment to bringing precision diagnostics to patients in Japan," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "We look forward to engaging with the PMDA and to improving outcomes for patients around the world."