Natera has applied to Japan's PMDA to approve its Signatera test as a companion diagnostic for muscle‑invasive bladder cancer, citing evidence from the Phase III IMvigor011 randomized trial. This follows Signatera's June PMDA approval for colorectal cancer and the FDA's clearance of the test as a companion diagnostic for adjuvant atezolizumab (Tecentriq). Signatera also carries a Category 1 NCCN recommendation for MRD‑guided use with adjuvant atezolizumab. Natera highlighted its laboratory certifications, extensive peer‑reviewed support, and the recent acquisition of Foresight Diagnostics.
Natera Seeks PMDA Approval for Signatera as Companion Diagnostic in Muscle‑Invasive Bladder Cancer
The test has also received a Category 1 recommendation in the NCCN guidelines for Signatera MRD-guided adjuvant atezolizumab. Credit: angellodeco / Shutterstock.com.
Natera, a leader in cell-free DNA and precision medicine, has submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) requesting approval of its Signatera test as a companion diagnostic for muscle-invasive bladder cancer (MIBC).
Regulatory Context and Supporting Evidence
The submission follows the PMDA's June approval of Signatera for colorectal cancer — the first molecular residual disease (MRD) test to receive regulatory clearance in Japan. Natera says the new MIBC application is supported by data from the randomized, double‑blind Phase III IMvigor011 trial.
Signatera has also received recent regulatory and guideline recognition internationally: the US Food and Drug Administration (FDA) cleared Signatera as a companion diagnostic for adjuvant atezolizumab (Tecentriq), and the test carries a Category 1 recommendation in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Bladder Cancer for MRD‑guided use with adjuvant atezolizumab.
Company Capabilities and Strategic Moves
Natera emphasized its commitment to bringing precision diagnostics to patients in Japan and globally. The company highlights that its assays are supported by more than 400 peer‑reviewed publications and that it operates US laboratories certified to ISO 13485 and ISO 27001 and accredited under the Clinical Laboratory Improvement Amendments (CLIA). Natera's lab facilities are located in Texas, California and Colorado.
In December 2025, Natera completed an all‑stock acquisition of Foresight Diagnostics, a business specializing in ultra‑sensitive MRD detection. The transaction included $275 million upfront and up to $175 million in earnouts tied to revenue and reimbursement milestones.
"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, Natera's oncology corporate chief medical officer and general manager. "We look forward to engaging with the PMDA and to improving outcomes for patients around the world."
Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
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