Natera (NTRA) said Friday the US Food and Drug Administration approved Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab to treat muscle-invasive bladder cancer.
The approval follows phase 3 trial results that showed Signatera molecular residual disease-positive patients treated with immunotherapy achieved improvements in disease-free survival and overall survival, while MRD-negative patients achieved 97% two-year OS with no adjuvant therapy, the company said.
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