Invivoscribe® Expands IVDR Portfolio with IdentiClone® Dx IGH Assay Certification

IdentiClone® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease.

Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). Commercial availability of the IVDR-certified assay is anticipated by early April 2026.

The IVDR replaces the former In Vitro Diagnostics Directive (IVDD), introducing significantly more stringent requirements for clinical evidence, performance evaluation, traceability, and post-market surveillance. 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 IdentiClone Dx IGH, are considered high-risk tests that play a critical role in disease diagnosis and patient management.

BSI (Netherlands), an EU-designated Notified Body, granted CE certification for the IdentiClone Dx IGH Assay following an independent conformity assessment under the IVDR. This approval marks Invivoscribe’s second successful IVDR certification, underscoring the company’s proven regulatory expertise and long-standing commitment to quality, compliance, and patient safety.

“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.”

The IdentiClone Dx IGH Assay is a PCR-based in vitro diagnostic device designed for the capillary electrophoresis-based detection of clonality in immunoglobulin heavy chain (IGH) gene rearrangements from peripheral blood specimens. The assay now includes integrated analysis software that automates data processing and interpretation, providing standardized, objective results with transparent reporting and full traceability. It serves as an adjunctive tool in the evaluation of patients suspected of having B-cell lymphoproliferative disorders, in which abnormal proliferation of a single B-cell clone produces a population of cells with identical (clonal) IGH gene rearrangements, a defining molecular hallmark of B-cell malignancies.

About Invivoscribe

Invivoscribe is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics^®. For more than thirty years, Invivoscribe has advanced the quality of healthcare worldwide by delivering high-quality, standardized reagents, diagnostic assays, and bioinformatics solutions that support precision medicine. The company has a proven track record of partnering with pharmaceutical and biotechnology organizations to support clinical trial testing through its global laboratory network in the United States, Germany, Japan, and China, as well as to develop and commercialize companion diagnostics, leveraging deep expertise in regulatory strategy and laboratory services. By offering both distributable diagnostic kits and clinical testing services through its globally located clinical laboratory subsidiaries, LabPMM^®, Invivoscribe is an ideal partner across the full diagnostic lifecycle - from development and clinical trials through regulatory submission and commercialization.

For more information, please visit www.invivoscribe.com, contactinquiry@invivoscribe.com, or follow Invivoscribe on LinkedIn.

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