On October 2, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported 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) (Press release, Natera, OCT 2, 2023, View Source [SID1234635584]).
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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 trial.
"With this initial step towards a PMA for Signatera, we are continuing to build on our longstanding engagement with the FDA," said Steve Chapman, chief executive officer of Natera. "This milestone reflects the significant efforts of our team in developing an FDA-grade quality and manufacturing system, a strong foundation designed to support future regulatory submissions across disease indications for Signatera and across product lines."
Signatera has previously been granted four Breakthrough Device Designations by the FDA, including the CDx claim in MIBC submitted in the PMA module package.
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted four Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to help identify recurrence earlier and optimize treatment decisions. The test has not been cleared or approved by the US Food and Drug Administration (FDA).