First IVDR‑Certified IGH Clonality Assay Supports Diagnosis of B-Cell Malignancies

Accurate identification of clonal immunoglobulin heavy chain (IGH) gene rearrangements is central to evaluating suspected B-cell lymphoproliferative disorders, where a single B-cell clone yields a defining molecular signature. A newly certified assay now provides the first IVDR-certified option in the European Union for IGH clonality detection.

The IdentiClone Dx IGH Assay from Invivoscribe (San Diego, CA, USA) has received European Union In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification. It is described as the first IVDR-certified assay for detecting clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. BSI (Netherlands), an EU-designated Notified Body, granted CE certification following an independent conformity assessment. Commercial availability of the IVDR-certified assay is anticipated by early April 2026.

Image: The assay serves as an adjunctive tool in evaluating patients suspected of B-cell lymphoproliferative disorders (photo courtesy of Shutterstock)

The assay is a PCR-based in vitro diagnostic designed for capillary electrophoresis-based detection of clonality in IGH gene rearrangements from peripheral blood specimens. It now includes integrated analysis software that automates data processing and interpretation. The software provides standardized, objective results with transparent reporting and full traceability.

IdentiClone Dx IGH serves as an adjunctive tool in evaluating patients suspected of having B-cell lymphoproliferative disorders, in which expansion of a single B-cell clone creates identical (clonal) IGH rearrangements that are a molecular hallmark of B-cell malignancies. Under IVDR, in vitro diagnostic devices are classified from Class A (lowest risk) to Class D (highest risk). Class C devices, such as this assay, are considered high-risk tests that play a critical role in disease diagnosis and patient management. This approval represents Invivoscribe’s second successful IVDR certification.

“Achieving IVDR certification for the IdentiClone Dx IGH Assay is a significant milestone for Invivoscribe and reflects decades of regulatory rigor, scientific excellence, and dedication to international standards,” said Jason Gerhold, Vice President of Global Regulatory, Quality, and Clinical Affairs at Invivoscribe. “This certification demonstrates our ability to meet the most stringent regulatory requirements and positions us to continue supporting laboratories and clinicians across the EU with high-quality, compliant diagnostic solutions.”

Related Links
Invivoscribe