Original from: Natera

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) in muscle-invasive bladder cancer (MIBC).

This approval supports the use of the Signatera test to guide adjuvant atezolizumab (Tecentriq®) treatment decisions in patients with MIBC. Natera expects to commercially launch Signatera for MIBC in Japan in the first half of 2027, following the PMDA’s approval of atezolizumab in MIBC.

Regulatory approval was supported by data from IMvigor011, a randomized, double-blind phase III clinical trial that evaluated Signatera-guided adjuvant atezolizumab in patients with MIBC. The trial included more than 20 participating sites in Japan, giving Japanese clinicians firsthand experience with Signatera-guided treatment in this setting.

This marks Signatera’s second PMDA authorization in Japan, after receiving approval in colorectal cancer in June 2026. It follows the U.S. Food and Drug Administration’s (FDA) approval of Signatera as a CDx for adjuvant atezolizumab in MIBC (and the approval by the FDA of atezolizumab), as well as the recently published Category 1 recommendation for 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 with approximately 20–25% of newly diagnosed cases classified as muscle-invasive.2 MIBC carries a higher risk of recurrence and greater treatment complexity than earlier-stage disease, underscoring the need for precision tools that can help clinicians individualize treatment decisions in the adjuvant setting.

“We look forward to launching this second Signatera MRD indication in Japan, giving patients with muscle-invasive bladder cancer a proven diagnostic tool to guide treatment decisions in the first year after surgery,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology, Natera. “We value our growing partnership with the Japanese oncology community, which has been a leader in adopting MRD into clinical trials and into clinical practice.”

Source: Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer