Invivoscribe secured CE-IVDR certification for its IdentiClone Dx IGH assay, designed to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected lymphoproliferative disorders. The company said it is the first IVDR-certified test kit for clonal IGH rearrangements in this setting. Under the EU’s IVDR framework, the test was classified as Class C, a high-risk tier given its role in patient diagnosis and management. Invivoscribe said it uses PCR with an electrophoresis readout on peripheral blood samples, integrating interpretation software for reporting and traceability. Commercial availability is expected next month, expanding Invivoscribe’s international diagnostic footprint for clonality testing used in hematology workflows.