Shots:
- Natera has submitted an application to Japan’s PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC)
- The submission expands the company’s presence in Japan, where Signatera became the country’s first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026
- Application is supported by data from the P-III (IMvigor011) trial & builds on milestones, incl. the US FDA approval of Signatera CDx as a companion diagnostic for adj. Tecentriq & a Category 1 NCCN recommendation for Signatera MRD-guided adj. Tecentriq in bladder cancer
Ref: Businesswire | Image: Natera | Press Release
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