Natera submitted a premarket approval (PMA) application to the US Food and Drug Administration for its Signatera CDx circulating tumor DNA assay as a companion diagnostic to guide adjuvant use of Genentech’s Tecentriq in muscle‑invasive bladder cancer. The submission includes Phase III IMvigor011 data showing that Signatera‑positive patients benefited from adjuvant atezolizumab with improvements in disease‑free and overall survival. Natera framed the PMA as a step toward routine MRD‑guided treatment decisions; if approved, Signatera could become the first MRD companion diagnostic for bladder cancer. The filing links a tumor‑informed MRD test to therapeutic selection and will be a regulatory test case for MRD assays as treatment‑guiding diagnostics.