Natera Submits First Premarket Approval Module To The FDA For Signatera
Portfolio Pulse from Benzinga Newsdesk
Natera, Inc. (NASDAQ:NTRA) has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera, a personalized and tumor-informed molecular residual disease (MRD) test. The submission is part of a series of applications for multiple cancer types, starting with a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC). The remaining modules, including software, analytical and clinical validation data, are expected to be submitted through 2025.
October 02, 2023 | 1:01 pm
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Natera's submission of the first module of its PMA application to the FDA for Signatera could potentially boost its stock in the short term as it indicates progress in the company's product pipeline.
The submission of the first module of the PMA application to the FDA is a significant step for Natera. It indicates that the company is making progress in its product pipeline, which could potentially attract investors and boost its stock in the short term. However, the final impact will depend on the FDA's response and the success of the remaining submissions.
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