Multiple late‑stage readouts in 2025 strengthened the commercial and clinical case for minimal residual disease (MRD) testing; the Phase III IMvigor011 trial used Natera’s tumor‑informed Signatera assay to select muscle‑invasive bladder cancer patients for adjuvant atezolizumab and reported a statistically significant survival benefit for Signatera‑positive patients receiving the checkpoint inhibitor. The IMvigor011 result is among the first randomized data supporting MRD as a decision‑making biomarker in solid tumors and has prompted Natera to finalize a premarket application for Signatera as a companion diagnostic. The readout and subsequent regulatory engagement mark a turning point for ctDNA‑based MRD tests and signal accelerating adoption in oncology trials and guideline considerations.
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