Natera submitted a premarket approval (PMA) application to the U.S. FDA for its Signatera CDx circulating tumor DNA assay as a companion diagnostic to guide adjuvant atezolizumab (Tecentriq) in muscle‑invasive bladder cancer. The PMA is backed by randomized Phase III IMvigor011 data showing improved disease‑free and overall survival in MRD‑positive patients treated with immunotherapy. If approved, Signatera would be the first companion diagnostic MRD test to direct adjuvant immunotherapy in this indication, enabling stratified treatment decisions and reducing unnecessary exposure to checkpoint inhibitors for MRD‑negative patients.