Natera's Signatera Test Gains Japan PMDA Approval for Bladder Cancer

Natera Inc. (NTRA) said Japan's Pharmaceuticals and Medical Devices Agency authorized its Signatera test as a companion diagnostic for muscle-invasive bladder cancer on Sept. 22, 2026. The approval permits Signatera, a circulating tumor DNA assay, to guide adjuvant treatment decisions in patients with the disease. Natera said the authorization expands the test's regulatory footprint in Japan. Financial terms were not disclosed. The company did not provide a timeline for commercial launch in the Japanese market.