Natera's Signatera wins EU IVDR certification for multiple cancers

Natera, Inc. (NASDAQ: NTRA) announced that its Signatera molecular residual disease (MRD) test has received Class C device certification under the European Union's In Vitro Diagnostic Regulation (IVDR), covering multiple cancer types.

Natera claims Signatera is the first personalized MRD test for solid tumors to receive IVDR certification in the EU. The certification covers use in 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.

The IVDR replaces the outgoing In Vitro Diagnostic Medical Devices Directive (IVDD), with a transition deadline in 2028. The certification process required review of the Signatera platform — including its assay, specimen collection kit, and associated software — against analytical and clinical validity standards, as well as quality system management requirements.

The EU certification follows two other regulatory milestones for the Signatera portfolio. In June 2026, Japan's Pharmaceuticals and Medical Devices Agency approved Signatera for patients with colorectal cancer. In May 2026, the U.S. Food and Drug Administration approved Signatera CDx as a companion diagnostic for patients with muscle-invasive bladder cancer.

"Achieving IVDR certification is a key milestone in Natera's plan to bring Signatera MRD testing to Europe," said Solomon Moshkevich, president of 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."

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