Signatera™ CDx
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Natera Submits Signatera™ CDx PMA to FDA
Businesswire· 2026-02-02 11:00
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the submission of its premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) for Signateraâ"¢ CDx for detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq®). This submission is supported by data from the randomized, double-blind, phase 3 IMvi. ...