NEW YORK – Natera announced on Monday that it has submitted the first premarket application module for its Signatera circulating tumor DNA (ctDNA) assay as a companion diagnostic for patients with muscle-invasive bladder cancer (MIBC) to the US Food and Drug Administration.
The module, submitted last Thursday, includes documentation on the manufacturing and quality control systems that the Austin, Texas-based company expects will support all future Signatera indications, as well as those of other Natera products.
Following modules for the MIBC indication will include software, as well as analytical and clinical validation data. Natera expects to submit these through 2025, pending completion of an ongoing registrational trial.
"This milestone reflects the significant efforts of our team in developing an FDA-grade quality and manufacturing system, [and] a strong foundation designed to support future regulatory submissions across disease indications for Signatera and across product lines," Natera CEO Steve Chapman said in a statement.
The FDA has granted Signatera four breakthrough device designations, including the MIBC CDx claim submitted in the current PMA module package.
Natera is also evaluating Signatera in monitoring neoadjuvant therapy response in a Phase II trial among breast cancer patients.