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Stock impact report

Natera Submits First PMA Module to the FDA for Signatera™

Natera, Inc. (NTRA) 
Last natera, inc. earnings: 2/26 04:10 pm Check Earnings Report
US:NASDAQ Investor Relations: investor.natera.com
Company Research Source: Business Wire
Lays groundwork for multiple submissions across cancer types, starting with CDx label in bladder cancer AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the submission of the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, as a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC).This module, submitted on September 28, included the required documentation regarding Natera’s manufacturing and quality control systems, which the Company expects will support all future indications for Signatera as well as other Natera products. The remaining modules for the Signatera MIBC indication, including software, analytical and clinical validation data, are expected to be submitted through 2025 upon completion of the ongoing registrational tria Show less Read more
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