Natera’s Signatera Secures IVDR Certification for Colorectal, Lung, Ovarian, Urothelial and Head & Neck Cancers
NTRA•Natera’s Signatera assay received IVDR certification covering colorectal, lung, ovarian, urothelial and head and neck cancers, enabling CE marking for tumor-informed ctDNA testing in the EU. This approval expands its regulatory footprint across multiple solid tumors, positioning the company to accelerate clinical adoption and revenue growth in Europe’s oncology market.
1. IVDR Certification Achieved
Natera announced that its Signatera tumor-informed ctDNA assay has met the EU’s In Vitro Diagnostic Regulation requirements, securing IVDR certification. The approval covers five solid tumor types—colorectal, lung, ovarian, urothelial, and head and neck cancers—paving the way for CE marking and distribution across European Union member states.
2. Market Impact and Next Steps
With CE marking enabled, Natera plans to accelerate clinical adoption of Signatera for recurrence monitoring and treatment guidance in European oncology centers. The company anticipates that regulatory clearance will support reimbursement discussions, broaden its diagnostic portfolio’s reach, and drive incremental revenue growth in its precision oncology business.
