Minimal residual disease (MRD) testing advanced toward clinical utility in 2025 after Phase III IMvigor011 used Natera’s Signatera to select muscle‑invasive bladder cancer patients for adjuvant Tecentriq (atezolizumab) and demonstrated a survival benefit for MRD‑positive patients. The randomized data mark a pivotal validation of ctDNA‑guided therapy selection and have prompted Natera to prepare a premarket submission to the FDA for Signatera as a companion diagnostic. The IMvigor011 results, presented at ESMO and discussed by clinicians including Jeanne Tie and Luis Diaz, catalyzed broader payer, guideline and regulatory conversations. The MRD space also saw commercial consolidation and reimbursement wins in 2025, positioning ctDNA assays as likely standard tools in adjuvant oncology decision‑making.
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