Natera Announces IVDR Certification for Signatera™ Across Multiple Cancers
Signatera is the first personalized molecular residual disease (MRD) test for solid tumors to receive IVDR certification in the EU
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received certification as a Class C device under the European Union’s In Vitro Diagnostic Regulation (IVDR).
The IVDR represents one of the world’s most rigorous regulatory frameworks for in vitro diagnostic medical devices, replacing the outgoing In Vitro Diagnostic Medical Devices Directive (IVDD). To obtain certification, the Signatera platform — including the assay, specimen collection kit, and associated software — underwent a comprehensive review against some of the most stringent standards in the medical industry, including evidence of analytical and clinical validity, as well as quality system management.
IVDR certification reduces the lead time and regulatory overhead for launching new clinical trials, and it ensures that Natera can continue offering Signatera to EU patients after the IVDD transition deadline in 2028.
