Natera's Signatera Wins EU Certification for Cancer Recurrence Monitoring
Certification allows Natera to keep offering the cancer-recurrence test across the EU as the bloc phases out its previous device framework.
Natera said that Signatera, its molecular residual disease (MRD) test for solid tumors, has received Class C certification under the European Union’s In Vitro Diagnostic Regulation (IVDR). ‘
The IVDR replaces the EU’s previous In Vitro Diagnostic Medical Devices Directive and requires more extensive evidence of analytical and clinical validity, plus quality system management, than the outgoing rules. Natera said the certification covered the full Signatera platform — the assay, specimen collection kit and associated software — and will let the company continue offering the test to EU patients after the prior directive’s transition deadline in 2028.
Under the certification, Signatera is indicated for adjuvant and surveillance monitoring across gastrointestinal, genitourinary, lung, head and neck, breast, skin and gynecological cancers, as well as diffuse large B-cell lymphoma, indolent non-Hodgkin’s lymphomas and pan-cancer immunotherapy monitoring.
In a statement, Natera said its test is the first personalized MRD test for solid tumors to clear that framework in the EU.
The certification follows two other recent regulatory decisions for Signatera: Japan’s Pharmaceuticals and Medical Devices Agency approved the test for colorectal cancer patients in June, and the FDA approved Signatera CDx as a companion diagnostic for muscle-invasive bladder cancer in May.
“MRD testing is redefining how we assess recurrence risk and guide treatment decisions for patients with cancer,” Julien Taieb, head of gastroenterology and gastrointestinal oncology at Université Paris-Cité, said in a statement. “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.”