Invivoscribe Expands IVDR Portfolio with Certification of IdentiClone Dx IGH Assay
Invivoscribe, a globally recognized leader in precision diagnostics and measurable residual disease (MRD) testing, has announced a major regulatory milestone with the successful certification of its IdentiClone Dx IGH Assay under the European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746. The assay has been classified as a Class C in vitro diagnostic device, reflecting its high clinical importance and risk category, and is expected to become commercially available across the European Union in early April 2026.
This achievement represents a significant step forward not only for Invivoscribe but also for the broader diagnostics landscape in Europe, as the IVDR framework introduces a new era of stricter regulatory oversight. The transition from the previous In Vitro Diagnostics Directive (IVDD) to IVDR has fundamentally reshaped the requirements for diagnostic manufacturers, placing greater emphasis on clinical evidence, performance validation, traceability, and ongoing post-market surveillance. For companies operating in this space, obtaining IVDR certification is widely regarded as both complex and resource-intensive, making successful approvals a strong indicator of regulatory excellence and product reliability.
Under IVDR, in vitro diagnostic devices are categorized into four classes—A through D—based on their intended use and associated risk to patients and public health. Class C devices, such as the IdentiClone Dx IGH Assay, are considered high-risk because they play a critical role in diagnosing serious diseases and guiding clinical decision-making. As a result, these devices must undergo rigorous conformity assessments conducted by designated notified bodies before they can be marketed within the European Union.
In this case, certification was granted by BSI Group (Netherlands), a European Union-designated Notified Body authorized to evaluate compliance with IVDR requirements. The approval followed an extensive independent review process, during which the assay’s analytical performance, clinical validity, and manufacturing quality systems were thoroughly assessed. Achieving CE marking under IVDR signifies that the IdentiClone Dx IGH Assay meets the highest standards for safety, performance, and regulatory compliance.
Importantly, this certification marks Invivoscribe’s second successful IVDR approval, further demonstrating the company’s ability to navigate the increasingly demanding regulatory environment. It also reinforces its long-standing commitment to delivering high-quality diagnostic solutions that meet international standards and support improved patient outcomes.
Jason Gerhold, Vice President of Global Regulatory, Quality, and Clinical Affairs at Invivoscribe, emphasized the significance of the milestone, noting that it reflects decades of scientific innovation, regulatory discipline, and dedication to excellence. According to Gerhold, the certification validates the company’s capacity to meet the stringent requirements of IVDR while continuing to provide reliable tools for laboratories and clinicians across Europe.
At the core of this announcement is the IdentiClone Dx IGH Assay itself, a polymerase chain reaction (PCR)-based diagnostic test designed to detect clonality in immunoglobulin heavy chain (IGH) gene rearrangements. The assay utilizes capillary electrophoresis technology to analyze DNA extracted from peripheral blood specimens, enabling the identification of clonal B-cell populations. Such clonality is a key molecular hallmark of B-cell lymphoproliferative disorders, a group of diseases characterized by the abnormal proliferation of B lymphocytes.
In clinical practice, distinguishing between reactive (benign) and clonal (malignant) lymphocyte populations is essential for accurate diagnosis and treatment planning. The IdentiClone Dx IGH Assay serves as an adjunctive diagnostic tool, providing valuable molecular insights that complement traditional methods such as histopathology, flow cytometry, and imaging studies. By detecting specific IGH gene rearrangements, the assay helps clinicians confirm the presence of a monoclonal B-cell population, which is indicative of conditions such as certain lymphomas and leukemias.
One of the notable advancements included in the IVDR-certified version of the assay is the integration of sophisticated analysis software. This software automates the processing and interpretation of test data, reducing the potential for human error and ensuring consistent, standardized results across different laboratories. Automated analysis also enhances efficiency, allowing laboratories to handle higher testing volumes while maintaining accuracy and reliability.
The software component further supports transparency and traceability—two key pillars of the IVDR framework. Detailed reporting features enable clinicians to clearly understand test results, while comprehensive data tracking ensures that all steps in the diagnostic process can be audited if necessary. These capabilities are particularly important in modern healthcare systems, where regulatory compliance and quality assurance are critical to maintaining patient safety.
The importance of such diagnostic tools is underscored by the growing demand for precision medicine approaches in oncology and hematology. As treatment strategies become increasingly tailored to the molecular characteristics of individual patients, the need for accurate and reliable diagnostic assays continues to rise. Tests like the IdentiClone Dx IGH Assay play a vital role in this paradigm shift by providing the molecular information required to guide personalized treatment decisions.
In addition to its clinical applications, the assay aligns with broader trends in laboratory medicine, including the adoption of standardized workflows and digital integration. By combining PCR-based detection with automated data analysis, Invivoscribe is helping laboratories transition toward more streamlined and reproducible diagnostic processes. This is particularly important in the context of multi-center studies and cross-border healthcare initiatives within the European Union, where consistency in testing and reporting is essential.
The successful IVDR certification also highlights Invivoscribe’s strategic focus on global regulatory compliance. As regulatory frameworks evolve worldwide, companies must continuously adapt to new requirements while maintaining the quality and performance of their products. Invivoscribe’s ability to secure multiple IVDR certifications demonstrates not only its technical expertise but also its commitment to staying ahead of regulatory changes and supporting its customers through these transitions.
From a market perspective, the commercial availability of the IVDR-certified IdentiClone Dx IGH Assay is expected to provide European laboratories with a trusted and compliant solution for clonality testing. With the IVDR implementation timeline creating challenges for many diagnostic manufacturers, the availability of certified assays is becoming increasingly important for laboratories seeking to maintain uninterrupted diagnostic services.
Furthermore, the certification may strengthen Invivoscribe’s position as a preferred partner for clinical laboratories and healthcare providers. By offering assays that meet the highest regulatory standards, the company can help its customers navigate the complexities of IVDR while continuing to deliver high-quality patient care.
Looking ahead, the approval of the IdentiClone Dx IGH Assay under IVDR sets the stage for further innovation and expansion within Invivoscribe’s product portfolio. As the company continues to develop new diagnostic solutions, it is likely to leverage the same rigorous standards and technological advancements that have contributed to this success.
In conclusion, the IVDR Class C certification of the IdentiClone Dx IGH Assay marks a major milestone for Invivoscribe and the field of molecular diagnostics. It reflects the company’s dedication to scientific excellence, regulatory compliance, and patient safety, while also addressing the growing need for advanced diagnostic tools in the era of precision medicine. With its anticipated launch in early April 2026, the assay is poised to play a critical role in supporting clinicians and laboratories across Europe in the accurate diagnosis and management of B-cell lymphoproliferative disorders.
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.
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