Natera submitted its Signatera MRD test to Japan’s PMDA seeking companion diagnostic approval in muscle-invasive bladder cancer. The application is supported by data from IMvigor011, a double-blind Phase 3 trial that randomized 250 ctDNA-positive patients after cystectomy to adjuvant Tecentriq (atezolizumab) or placebo. Natera reported that disease-free survival nearly doubled in the Tecentriq arm (9.9 months vs 4.8 months), with median overall survival also longer (32.8 months vs 21.1). Natera also pointed to survival at two years, where 62.8% of patients remained alive on Tecentriq versus 46.9% on placebo. With the FDA already having approved Signatera as a companion diagnostic for adjuvant Tecentriq earlier this year and Japan approving an MRD version for colorectal cancer, the PMDA filing signals continued expansion of MRD-guided immunotherapy strategies into new geographies.