Invivoscribe secured CE-IVDR certification for its IdentiClone Dx IGH assay, a test designed to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected B-cell lymphoproliferative disorders. Under the EU’s IVDR framework, the assay is designated as Class C, meaning it is treated as a higher-risk diagnostic device. Invivoscribe said the kit is intended to be commercially available next month and uses peripheral blood samples with PCR plus electrophoresis readout and integrated interpretation software. The company described the certification as its first IVDR-certified test kit for clonal immunoglobulin gene rearrangements, strengthening its position in standardized Europe-wide adoption for diagnostics that guide patient management. This milestone matters for biotech and CDx developers because IVDR-compliant pathways can determine whether tests scale across EU markets and whether clinicians can consistently implement clonality monitoring.