Natera Submits Signatera™ CDx PMA to FDA [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
AUSTIN, Texas, February 02, 2026 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 Signatera™ 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 IMvigor011 clinical trial, which met its primary endpoint and demonstrated the benefits of Signatera-guided therapy in MIBC. In the study, Signatera-positive patients treated with atezolizumab (Tecentriq®) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival, compared with placebo. The trial also showed that Signatera-negative patients had a low risk of recurrence without adjuvant immunotherapy. Results were featured in
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