Adaptive Gains IVDR Certification for clonoSEQ® in EU

Adaptive Biotechnologies Corporation has announced that its clonoSEQ® assay has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). This certification marks a significant milestone in the evolution of medical diagnostics, particularly for assessing minimal residual disease (MRD) in patients with lymphoid malignancies. 

The EU recently replaced its In Vitro Diagnostics Directive (IVDD) with the more stringent IVDR standards to enhance quality and safety in medical diagnostics. Adaptive Biotechnologies collaborated with the EU-notified body, BSI, to transition their previously IVDD CE-marked product, the clonoSEQ Assay B-Cell Reagent Set, to comply with the new regulations. As a result, clonoSEQ has become the first and only test to achieve IVDR certification for MRD detection in lymphoid malignancies.

The clonoSEQ assay's intended use under IVDR is comprehensive, allowing for the assessment of MRD status and monitoring changes in disease burden during and after treatment in patients with B-cell malignancies. This certification underscores Adaptive Biotechnologies' commitment to delivering superior MRD testing to European healthcare professionals, patients, and clinical trial sponsors. Susan Bobulsky, Chief Commercial Officer for MRD at Adaptive Biotechnologies, emphasized the significance of this milestone, highlighting the ability for European labs to offer IVDR-compliant clonoSEQ MRD testing locally and in clinical trials.

MRD testing is increasingly integrated into patient care, offering a robust method to measure disease risk and track disease progression, aiding oncologists in crafting personalized treatment plans. Mohamad Mohty, M.D., Ph.D., from Saint-Antoine Hospital and Sorbonne University in Paris, highlighted the value of MRD assessment for providing individualized treatment to improve care standards for blood cancer patients. The adoption of IVDR ensures that clonoSEQ remains a reliable and validated tool for such assessments.

Apart from clinical applications, clonoSEQ is also a preferred choice for MRD assessment in drug development and clinical research in hematologic malignancies. The assay has been included in numerous global studies for therapies approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The IVDR certification allows Adaptive to comply with clinical trial regulations for testing samples from EU subjects, facilitating seamless sample transfers from the EU to Adaptive’s laboratory in Seattle, Washington.

Carolina Terragna, Ph.D., from the Laboratory of Molecular Biology at the University Hospital of Bologna IRCCS, noted that clonoSEQ is a highly validated prognostic test that supports both therapeutic decision-making and expediting clinical trials. The IVDR approval ensures continued access to this reliable method for measuring treatment efficacy in lymphoid malignancies in Europe.

clonoSEQ has established itself as a leading tool for blood cancer MRD assessment, supported by over 150 peer-reviewed publications and utilized by more than 3,700 clinicians in the past year. The assay is currently being used in over 160 active biopharma-sponsored trials. In the EU, clonoSEQ is available to oncologists through technology transfer partnerships with major academic laboratories, with testing currently conducted in France, Italy, Spain, and Germany. Additional partnerships are expected to launch later in 2024, expanding the availability of clonoSEQ testing in the EU and surrounding markets.

clonoSEQ is the first FDA-cleared in vitro diagnostic test for detecting MRD in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL), and in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). It leverages Adaptive Biotechnologies' proprietary immune medicine platform to identify and quantify malignant DNA sequences, enabling clinicians to monitor MRD during and after treatment, predict patient outcomes, and detect potential relapses early. Clinical practice guidelines recognize MRD status as a reliable indicator of clinical outcomes and response to therapy, with clonoSEQ's measurements strongly associated with patient outcomes in CLL, MM, ALL, and DLBCL.

Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the adaptive immune system to transform disease diagnosis and treatment. Their immune medicine platform decodes the adaptive immune system's genetics to develop clinical diagnostics and therapeutics, partnering with biopharmaceutical companies and developing products for cancer, autoimmune disorders, and infectious diseases. Their goal is to create immune-driven clinical products tailored to individual patients.

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