Natera’s Signatera Earns IVDR Certification for Solid Tumor MRD Testing

Natera’s Signatera has received certification as a Class C device under the European Union’s In Vitro Diagnostic Regulation (IVDR), becoming the first personalized MRD test for solid tumors to achieve IVDR certification in the EU. The certification allows Signatera to be used in the adjuvant and surveillance settings across gastrointestinal and genitourinary malignancies, non‑small cell lung cancer, head and neck cancer, breast and skin cancers, gynecological malignancies, diffuse large B‑cell lymphoma, indolent non‑Hodgkin’s lymphomas, and for pan‑cancer immunotherapy monitoring. The designation provides a path for continued test availability in the EU after the IVDD transition deadline in 2028.

The Signatera platform, which includes the assay, specimen collection kit, and associated software, underwent a comprehensive review to obtain IVDR certification. The assessment evaluated analytical and clinical validity, along with quality system management. As IVDR replaces the prior In Vitro Diagnostic Medical Devices Directive (IVDD), the certification reflects compliance with one of the world’s most rigorous regulatory frameworks for in vitro diagnostics.

Photo courtesy of Natera

According to the company, IVDR certification is expected to reduce lead time and regulatory overhead for launching new clinical trials that incorporate the test. The certification follows two recent milestones for the Signatera portfolio: approval in June 2026 from Japan’s Pharmaceuticals and Medical Devices Agency for patients with colorectal cancer, and U.S. Food and Drug Administration (FDA) approval in May 2026 of Signatera CDx as a companion diagnostic for patients with muscle‑invasive bladder cancer. The company noted that these authorizations, together with IVDR certification, are supported by extensive clinical and analytical evidence across tumor types and clinical settings.

“MRD testing is redefining how we assess recurrence risk and guide treatment decisions for patients with cancer. 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,” said Julien Taieb, M.D., Ph.D., head of the gastroenterology and gastrointestinal oncology department at the Université Paris‑Cité.

“Achieving IVDR certification is a key milestone in Natera’s plan to bring Signatera MRD testing to Europe. Backed by extensive clinical evidence across multiple cancer types, this builds on our recent regulatory approvals in both the United States and Japan,” said Solomon Moshkevich, president, clinical diagnostics at Natera.