AUSTIN, Texas, August 5, 2026

Natera, Inc. has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval of its Signatera™ assay as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC). The submission follows the test’s recent U.S. FDA approval as a companion diagnostic for adjuvant atezolizumab (Tecentriq®) in MIBC and builds on Signatera’s expanding regulatory presence in Japan, where it became the country’s first PMDA-approved molecular residual disease (MRD) test following approval in colorectal cancer (CRC) in June 2026. The latest filing further strengthens Natera’s strategy to expand access to precision oncology diagnostics across international markets.

Phase 3 Evidence Supports Companion Diagnostic Application

The PMDA submission is supported by data from the Phase 3 IMvigor011 clinical trial, a randomized, double-blind study evaluating the clinical utility of MRD-guided treatment in patients with muscle-invasive bladder cancer. The application also builds upon Signatera’s growing body of clinical evidence and recent regulatory milestones, including U.S. FDA approval as a companion diagnostic for Tecentriq® (atezolizumab) and its inclusion as a Category 1 recommendation in the National Comprehensive Cancer Network (NCCN®) Clinical Practice Guidelines for MRD-guided adjuvant atezolizumab therapy in bladder cancer. These achievements reinforce Signatera’s role in enabling personalized treatment decisions by detecting molecular residual disease after surgery.

Precision MRD Testing Addresses High-Risk Bladder Cancer

Muscle-invasive bladder cancer (MIBC) is an aggressive subtype accounting for approximately 20–25% of newly diagnosed bladder cancer cases worldwide and is associated with a significantly higher risk of recurrence and disease progression. More than 34,000 people are diagnosed with bladder cancer annually in Japan, highlighting the need for advanced diagnostic tools that can identify patients most likely to benefit from adjuvant therapy. Signatera is a personalized, tumor-informed cell-free DNA assay designed to detect minimal or molecular residual disease (MRD) following treatment, allowing clinicians to better identify patients at increased risk of recurrence and optimize therapeutic strategies. According to Dr. Alexey Aleshin, Corporate Chief Medical Officer and General Manager of Oncology at Natera, the submission reflects the company’s commitment to expanding access to precision diagnostics that improve clinical outcomes for cancer patients worldwide.

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PMDA Filing Strengthens Natera’s Global Precision Oncology Strategy

The PMDA submission marks another important milestone in Natera’s global expansion strategy, reinforcing the company’s leadership in cell-free DNA diagnostics and precision medicine. By pursuing regulatory approval in Japan for Signatera as a companion diagnostic in MIBC, Natera aims to broaden the availability of MRD-guided cancer management, enabling more personalized treatment decisions for patients with aggressive bladder cancer. Combined with recent regulatory successes in both the United States and Japan, the submission highlights the company’s continued investment in advancing precision oncology, expanding the clinical utility of Signatera, and supporting the integration of molecular diagnostics into routine cancer care worldwide.

Source: Natera press release