Invivoscribe Achieves IVDR Class C Certification for B-Cell Lymphoma Diagnostic Assay in Europe
Key Insights
Invivoscribe (search)'s IdentiClone Dx IGH Assay (search) receives In Vitro Diagnostic Regulation (IVDR) Class C certification from BSI Netherlands, marking the first IVDR-certified test for detecting clonal immunoglobulin gene rearrangements in suspected B-cell lymphoproliferative disease (search).
The PCR-based diagnostic device uses capillary electrophoresis to detect clonality in immunoglobulin heavy chain (search) gene rearrangements from peripheral blood specimens, serving as an adjunctive tool for evaluating B-cell malignancies (search).
Commercial availability of the IVDR-certified assay is anticipated by early April 2026, representing Invivoscribe (search)'s second successful IVDR certification under the stringent European regulatory framework.
Invivoscribe (search) has achieved a significant regulatory milestone with the In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification of its IdentiClone Dx IGH Assay (search) in the European Union. The San Diego-based precision diagnostics company announced that BSI (Netherlands) (search), an EU-designated Notified Body, granted CE certification following an independent conformity assessment under the IVDR framework. Commercial availability of the certified assay is expected by early April 2026.
First IVDR-Certified Assay for B-Cell Lymphoma Detection
The IdentiClone Dx IGH Assay (search) represents the first IVDR-certified diagnostic test specifically designed for detecting clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease (search). This PCR-based in vitro diagnostic device utilizes capillary electrophoresis-based detection to identify clonality in immunoglobulin heavy chain (search) (IGH (search)) gene rearrangements from peripheral blood specimens.
The assay serves as an adjunctive tool in evaluating patients suspected of having B-cell lymphoproliferative disorders, where abnormal proliferation of a single B-cell clone produces a population of cells with identical (clonal) IGH (search) gene rearrangements. These clonal rearrangements represent a defining molecular hallmark of B-cell malignancies (search).
Enhanced Diagnostic Capabilities with Integrated Software
The certified assay now includes integrated analysis software that automates data processing and interpretation, providing standardized, objective results with transparent reporting and full traceability. This technological enhancement aims to improve diagnostic consistency and reliability for laboratories and clinicians across the European Union.
Stringent IVDR Compliance Achievement
The IVDR certification represents compliance with significantly more stringent regulatory requirements compared to the former In Vitro Diagnostics Directive (IVDD). Under IVDR, in vitro diagnostic devices are classified according to risk from Class A (lowest risk) to Class D (highest risk). Class C devices, such as the IdentiClone Dx IGH (search), are considered high-risk tests that play a critical role in disease diagnosis and patient management.
The IVDR framework introduces enhanced requirements for clinical evidence, performance evaluation, traceability, and post-market surveillance. This certification marks Invivoscribe (search)'s second successful IVDR certification, demonstrating the company's regulatory expertise and commitment to quality standards.
"Achieving IVDR certification for the IdentiClone Dx IGH Assay (search) is a significant milestone for Invivoscribe (search) 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."
Global Diagnostic Leadership
Invivoscribe (search) operates as a global, vertically integrated biotechnology company focused on precision diagnostics and measurable residual disease testing. The company has maintained operations for more than thirty years, delivering standardized reagents, diagnostic assays, and bioinformatics solutions that support precision medicine initiatives.
The company maintains a global laboratory network spanning the United States, Germany, Japan, and China, supporting clinical trial testing and companion diagnostic development. Through its clinical laboratory subsidiaries, LabPMM (search), Invivoscribe (search) provides both distributable diagnostic kits and clinical testing services across the diagnostic lifecycle from development through commercialization.