Cell-free DNA and precision medicine company Natera has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval for its Signatera test as a companion diagnostic in muscle-invasive bladder cancer (MIBC).
This move follows the previous PMDA approval of Signatera for colorectal cancer in June, making it the first molecular residual disease (MRD) test to achieve such approval in the country.
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The new application is supported by data from IMvigor011, a randomised, double-blind Phase III clinical trial.
It also comes after recent developments for Signatera in MIBC, including approval by the US Food and Drug Administration (FDA) as a companion diagnostic for adjuvant atezolizumab (Tecentriq).
The test has also received a Category 1 recommendation in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Bladder Cancer for the use of Signatera MRD-guided adjuvant atezolizumab.
Natera oncology corporate chief medical officer and general manager Alexey Aleshin said: “Signatera is a proven tool in bladder cancer management, and this submission reflects our commitment to bringing precision diagnostics to patients in Japan.
“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.
Natera focuses on cell-free DNA and precision medicine, with interests in oncology, women’s health, and organ health.
According to the company, its tests have been supported by more than 400 peer-reviewed publications.
Natera operates laboratories certified by a range of standards in the US, including ISO 13485 and ISO 27001, as well as accreditation under the Clinical Laboratory Improvement Amendments (CLIA). Its facilities are located in Texas, California and Colorado.
In December 2025, Natera acquired Foresight Diagnostics, a business known for its ultra-sensitive MRD detection, in an all-stock transaction.
The transaction comprises an upfront payment of $275m and an additional $175m in earnouts based on revenue and reimbursement milestones.
