Natera Submits Signatera CDx Premarket Approval Application to FDA

Reuters02-02

Natera Submits Signatera CDx Premarket Approval Application to FDA

Natera Inc. has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Signatera™ CDx test, intended for the detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq®). The submission is supported by data from the phase 3 IMvigor011 clinical trial, which demonstrated improved disease-free survival and overall survival in Signatera-positive patients treated with atezolizumab, compared to placebo. If approved, Signatera CDx could become the first companion diagnostic MRD test to guide treatment decisions for patients with muscle-invasive bladder cancer.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Natera Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260129560151) on February 02, 2026, and is solely responsible for the information contained therein.

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