Invivoscribe obtained CE-IVDR certification for its IdentiClone Dx IGH assay, a kit designed to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected lymphoproliferative disorders. The company said the assay is the first IVDR-certified test kit for clonal IGH gene rearrangements in this context. The test is classified as Class C under IVDR, which Invivoscribe described as high-risk due to the role of such assays in diagnosis and patient management. The company also highlighted integrated PCR and electrophoresis workflows with software for interpretation and full traceability. Invivoscribe expects commercial availability next month, positioning the company to expand European uptake for B-cell clonality assessment. The announcement adds to a continuing European diagnostics shift toward stricter regulatory standards for molecular assays. For the broader sector, IVDR certification remains a key gating item for scaling adoption across labs and screening networks, especially for tests tied to oncology and hematology decision-making.