Minimal residual disease (MRD) testing saw multiple high‑profile trial readouts and commercial consolidations in 2025, with the Phase III IMvigor011 trial using Natera’s Signatera test presenting randomized evidence of MRD‑guided adjuvant immunotherapy benefit in muscle‑invasive bladder cancer. The positive results strengthen MRD’s case as a predictive biomarker and accelerate conversations with payers and regulators about clinical utility and companion diagnostic pathways. The space also experienced acquisitions and reimbursement wins, reflecting growing clinical validation but ongoing challenges around standardization, regulatory clearance and integration into treatment algorithms. Developers and diagnostics labs are positioning to capture MRD’s potential across tumor types while navigating requirements for clinical‑grade assays and companion diagnostic claims. Clinicians should note that randomized MRD evidence raises the likelihood of guideline incorporation; companies with validated tumor‑informed assays may lead early adoption and reimbursement negotiations.
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