Natera submitted its Signatera MRD test to Japan’s PMDA for companion diagnostic approval in muscle-invasive bladder cancer. The filing is supported by data from IMvigor011, which tested MRD-positive post-cystectomy patients treated with Tecentriq (atezolizumab) versus placebo. In IMvigor011, disease-free survival nearly doubled in the Tecentriq arm (9.9 months vs 4.8 months). Overall survival also favored Tecentriq, with 2-year survival of 62.8% versus 46.9% in the placebo group, reinforcing MRD-driven treatment selection. This submission follows earlier momentum for Signatera in other tumor types, including PMDA approval for colorectal cancer earlier this year, and it extends MRD-based decision support beyond liquid biopsy into Japan’s regulatory framework for oncology testing.