Natera Submits Signatera™ to Japan’s PMDA for Approval as a Companion Diagnostic in Muscle-Invasive Bladder Cancer
Follows Signatera’s recent U.S. FDA approval in MIBC and Japanese PMDA approval in CRC
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that it has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval of the Signatera test in muscle-invasive bladder cancer (MIBC) as a companion diagnostic (CDx).
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.
