Natera, a global leader in cell-free DNA testing, has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera. Signatera is Natera's personalized and tumor-informed molecular residual disease (MRD) test, intended to be used as a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC). This initial module, submitted on September 28, includes documentation regarding Natera's manufacturing and quality control systems, which will support future indications for Signatera and other Natera products. Additional modules for Signatera's MIBC indication, including software, analytical, and clinical validation data, will be submitted through 2025 upon the completion of an ongoing registrational trial. Signatera has received four Breakthrough Device Designations from the FDA, including the CDx claim for MIBC.