Invivoscribe obtained CE-IVDR certification for its IdentiClone Dx IGH assay, a test intended to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected B-cell lymphoproliferative disorders. The company said the assay is the first IVDR-certified kit for clonal IGH rearrangements. Under the EU’s IVDR framework, the IdentiClone Dx IGH test is classified as Class C (high-risk), requiring stringent documentation and oversight. Invivoscribe said it expects commercial availability in Europe and countries recognizing the CE mark next month, positioning the test to support patient stratification and monitoring decisions.