Clinical trial readouts and commercial consolidation in 2025 strengthened the minimal residual disease (MRD) testing market, with the Phase III IMvigor011 trial standing out as randomized data validating tumor‑informed ctDNA testing for adjuvant immunotherapy selection. The IMvigor011 readout used Natera’s Signatera to identify muscle‑invasive bladder cancer patients who benefited from adjuvant atezolizumab, marking a pivotal regulatory and guideline‑relevant data point. The year also saw acquisitions, reimbursement wins and regulatory engagement that increased MRD’s clinical credibility across tumor types. Natera is finalizing a premarket application to the FDA for Signatera as a companion diagnostic to guide adjuvant therapy in bladder cancer, signaling a pathway for MRD assays to influence standard‑of‑care decisions. Analysts and clinicians expect additional randomized MRD studies and guideline discussion next year; payers will scrutinize clinical utility and cost‑effectiveness when considering coverage for MRD‑guided strategies.
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