Orignal from: Natera
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.
Under this certification, Signatera is indicated for use in the adjuvant and surveillance settings across gastrointestinal malignancies, genitourinary malignancies, non-small cell lung cancer, head and neck cancer, breast cancer, skin cancer, gynecological malignancies, diffuse large B-cell lymphoma, indolent non-Hodgkin's lymphomas, and pan-cancer immunotherapy monitoring.
Certification was supported by extensive clinical and analytical evidence demonstrating Signatera’s performance across multiple tumor types and clinical settings. It follows two significant regulatory milestones for the Signatera portfolio: in June 2026, Signatera received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for patients with colorectal cancer; and in May 2026, the U.S. Food and Drug Administration approved Signatera™ CDx as a companion diagnostic for patients with muscle-invasive bladder cancer.
“MRD testing is redefining how we assess recurrence risk and guide treatment decisions for patients with cancer,” said Julien Taieb, M.D., Ph.D., head of the gastroenterology and gastrointestinal oncology department at the Université Paris-Cité. “This certification for Signatera is an important milestone as it will enhance access to personalized MRD testing for patients across Europe within a more rigorous regulatory framework.”
“Achieving IVDR certification is a key milestone in Natera’s plan to bring Signatera MRD testing to Europe,” said Solomon Moshkevich, president, clinical diagnostics at Natera. “Backed by extensive clinical evidence across multiple cancer types, this builds on our recent regulatory approvals in both the United States and Japan.”
Source: Natera Announces IVDR Certification for Signatera™ Across Multiple Cancers
