Natera submitted its Signatera MRD test to Japan’s PMDA seeking CDx approval in muscle-invasive bladder cancer. The filing is supported by data from IMvigor011, a double-blind Phase 3 study in ctDNA-positive patients following cystectomy, where Tecentriq-treated participants showed markedly longer disease-free and overall survival. The submission follows FDA approval of Signatera as a companion diagnostic for adjuvant Tecentriq in the U.S. and mirrors regulatory progress earlier this year in colorectal cancer within Japan. The step extends Natera’s push to embed MRD testing across oncology stages and geographies. For providers and payers, the move highlights how ctDNA monitoring is becoming increasingly integrated into treatment decision-making—where regulatory coverage can unlock reimbursement pathways and accelerate clinical adoption.