Adaptive Announces IVDR Certification for clonoSEQ® in European Union

Core Viewpoint - Adaptive Biotechnologies Corporation has announced that its clonoSEQ® test has received IVDR Class C certification in the European Union, marking it as the first and only test certified for detecting minimal residual disease (MRD) in lymphoid malignancies [1][2]. Company Overview - Adaptive Biotechnologies is a commercial-stage biotechnology company focused on translating the genetics of the adaptive immune system into clinical products for disease diagnosis and treatment [9]. - The company aims to develop immune-driven clinical products tailored to individual patients, addressing diseases such as cancer, autoimmune disorders, and infectious diseases [9]. Product Details - clonoSEQ is the first FDA-cleared in vitro diagnostic test for detecting MRD in patients with multiple myeloma, B-cell acute lymphoblastic leukemia, and chronic lymphocytic leukemia [6]. - The test leverages a proprietary immune medicine platform to identify and quantify specific DNA sequences in malignant cells, providing standardized and sensitive MRD measurements [7]. Regulatory Achievement - The transition from the previous In Vitro Diagnostics Directive (IVDD) to the more stringent In Vitro Diagnostic Regulation (IVDR) reflects significant advancements in medical diagnostics [2]. - clonoSEQ's IVDR certification allows for compliance with rigorous safety and quality standards, enhancing its credibility among healthcare professionals [4]. Clinical Impact - clonoSEQ is increasingly adopted in patient care, providing real-time insights into disease progression and enabling personalized treatment approaches for patients with lymphoid malignancies [3]. - The test has been included in numerous global clinical trials for therapies approved by the European Medicines Agency and the U.S. Food and Drug Administration [4]. Market Presence - clonoSEQ is utilized by over 3,700 clinicians and is involved in more than 160 active biopharma-sponsored trials [5]. - The test is available in several European countries through partnerships with major academic laboratories, with plans for further expansion in 2024 [5].