Adaptive Announces IVDR Certification for clonoSEQ® in the European Union
Friday, August 30, 2024
Adaptive Biotechnologies Corporation, a commercial-stage biotechnology company focused on translating the genetics of the adaptive immune system into clinical products for diagnosing and treating diseases, today announced that its clonoSEQ® assay has been granted In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU).
The medical diagnostics industry has seen rapid technological advancements, prompting the EU to replace the older In Vitro Diagnostics Directive (IVDD) with the more rigorous IVDR standards, which emphasize enhanced quality and safety. Adaptive Biotechnologies collaborated with the EU's notified body, BSI, to achieve this certification, transitioning its previously IVDD CE-marked product, the clonoSEQ Assay B-Cell Reagent Set, to comply with the new IVDR requirements. With this certification, clonoSEQ becomes the first and only test to obtain IVDR certification for detecting minimal residual disease (MRD) in lymphoid malignancies. The IVDR certification broadens clonoSEQ’s intended use, allowing for comprehensive assessment of MRD status and monitoring of disease progression during and after treatment in patients 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 more integral to patient care, clonoSEQ offers a robust and versatile tool for assessing risk status in patients with lymphoid malignancies, providing real-time insights into disease progression that can support more personalized treatment strategies.
“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.”
Beyond clinical use, clonoSEQ is the preferred MRD testing method for drug developers conducting clinical research in hematologic malignancies. The assay has been included in numerous global, label-enabling studies for therapies approved by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in recent years. With IVDR certification, Adaptive Biotechnologies can now meet the clinical trial regulations for testing samples from EU subjects, with the ability to seamlessly transfer clinical trial samples from the EU to its laboratory in Seattle, Washington.
“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.”
clonoSEQ is recognized as a leading tool in MRD assessment for blood cancers, supported by over 150 peer-reviewed publications and used by more than 3,700 clinicians in the past year alone. Additionally, clonoSEQ is currently utilized in over 160 active biopharma-sponsored trials. In the EU, clonoSEQ testing is available to oncologists through technology transfer partnerships with major academic laboratories. Currently, clonoSEQ testing is conducted in France by Centre Hospitalier Universitaire (CHU) Toulouse, in Italy by Hospital of Bologna, in Spain by Hospital 12 de Octubre, and in Germany by HPH laboratory. More technology transfer partnerships are expected to launch in the EU and surrounding regions later in 2024.
Source: adaptivebiotech.com
