Natera said its Signatera minimal residual disease platform (ctDNA) received IVDR certification for multiple cancer indications. The certification covers the assay platform, specimen collection kit, and associated software following evidence of analytical and clinical validity. The decision strengthens the regulatory footing for ultrasensitive oncology monitoring in Europe, where IVDR status can be a key determinant of adoption in clinical workflows. MRD tests are increasingly used to refine prognosis and treatment decisions in settings spanning adjuvant and ongoing disease monitoring. For biotech and diagnostics providers, IVDR clearance reduces friction for expanding customer bases and supports broader uptake in multinational clinical programs.
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