Adaptive Biotechnologies, a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that clonoSEQ has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU).
The medical diagnostics field has experienced significant technological advancement in recent years, leading the EU to replace its previous regulatory framework, the In Vitro Diagnostics Directive (IVDD), with a more stringent set of standards for quality and safety, known as IVDR. Adaptive worked with EU notified body BSI to complete the certification process and transition the company’s IVDD CE-marked product, the clonoSEQ Assay B-Cell Reagent Set, to this new regulation. clonoSEQ is now the first and only test to receive IVDR certification for the detection of minimal residual disease (MRD) in lymphoid malignancies. clonoSEQ’s intended use under IVDR is broad in scope, allowing for assessment of MRD status and changes in disease burden during and after treatment in patients diagnosed with B-cell malignancies.
“IVDR certification further distinguishes clonoSEQ and underscores Adaptive’s commitment to providing best-in-class MRD testing for European healthcare professionals, patients and clinical trial sponsors,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “We’re pleased to be the first CE-marked MRD test to meet this regulatory standard, to enable European labs to offer IVDR-compliant clonoSEQ MRD testing locally, and to offer IVDR-compliant testing in clinical trials to support biopharmaceutical clients.”
As MRD testing becomes increasingly adopted in patient care, clonoSEQ provides a powerful and dynamic way to measure risk status for patients with lymphoid malignancies and yields real-time insights into disease progression that can help oncologists provide a more personalized treatment approach.
“MRD assessment is an incredibly valuable tool for providing individualized treatment to improve standards of care for blood cancer patients,” said Mohamad Mohty, M.D., Ph.D., professor of hematology and head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University in Paris, France. “With the adoption of the more rigorous standards established by IVDR, when utilizing clonoSEQ, we can trust that we are using a fully validated assay following the strictest standards for safety, quality and performance in our practice.”
In addition to clinical use, clonoSEQ is the test of choice for MRD assessment among drug developers performing clinical research in hematologic malignancies. The assay has been included in global, label-enabling studies for a multitude of therapies approved by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) over the past several years. IVDR certification allows Adaptive to meet the clinical trial regulations for testing EU subjects’ samples, and sponsors can seamlessly send clinical trial subjects’ samples from the EU to Adaptive’s Seattle, Washington laboratory.
“clonoSEQ is a highly validated prognostic test that can support therapeutic decision-making in the daily management of patients as well as potentially expedite clinical trials to support drug development,” said Carolina Terragna, Ph.D., executive biologist, Laboratory of Molecular Biology, University Hospital of Bologna IRCCS. “The IVDR approval ensures continued access in Europe to the most reliable way to measure treatment efficacy in lymphoid malignancies.”
