Natera Submits First Module of PMA Application for Signatera as Companion Diagnostic for Muscle-Invasive Bladder Cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, announced that it has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera as a companion diagnostic for patients with muscle invasive bladder cancer (MIBC).
The module, submitted on September 28, encompasses documentation related to Natera’s manufacturing and quality control systems. The company anticipates that this submission will serve as the foundation not only for future indications for Signatera but also for other Natera products. The remaining modules for the Signatera MIBC indication, which will encompass software, analytical, and clinical validation data, are scheduled for submission over the course of 2025 upon the conclusion of the ongoing registrational trial.
Steve Chapman, CEO of Natera, emphasized the significance of this initial PMA step, stating, “With this initial step towards a PMA for Signatera, we are continuing to build on our longstanding engagement with the FDA. 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 is currently covered for Medicare for monitoring disease progression, disease recurrence, or relapse for patients with Colorectal cancer, muscle invasive bladder cancer , and stage IIb or higher breast cancer. It is also covered for monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor. The Centers for Medicare & Medicaid Services (CMS) has granted ADLT status for the Signatera molecular residual disease (MRD) test with a reimbursement rate of $3,920 under the 2023 Clinical Laboratory Fee Schedule per test performed. The test detects circulating tumor DNA (ctDNA) and is designed for monitoring cancer treatment and assessing molecular residual disease (MRD) in patients with a previous cancer diagnosis. Signatera is highly personalized and tumor-informed, tailoring each blood test to an individual’s specific clonal mutation signature found in their tumor. Its primary goal is to detect and measure any remaining cancer cells in the body, even at levels as low as a single tumor molecule in a blood sample. This capability helps in the early detection of cancer recurrence and aids in optimizing treatment strategies. A study published in the Journal of Clinical Oncology showed that Signatera was 100% sensitive to relapse in patients with muscle invasive bladder cancer with an average lead time of 2.8 months.