Natera submitted a premarket approval (PMA) application to the FDA for Signatera CDx as a companion diagnostic to guide adjuvant atezolizumab (Tecentriq) in muscle‑invasive bladder cancer. The filing is supported by randomized Phase III IMvigor011 data showing that MRD‑positive patients who received atezolizumab had statistically significant improvements in disease‑free and overall survival versus placebo, while MRD‑negative patients had low recurrence risk without adjuvant immunotherapy. If approved, Signatera would be among the first circulating tumor DNA (ctDNA) MRD tests cleared as a companion diagnostic to direct adjuvant immunotherapy, potentially changing post‑surgical decision making in bladder cancer and accelerating adoption of MRD‑guided oncology approaches.
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