Adaptive Announces IVDR Certification for clonoSEQ in the European Union Page 1

clonoSEQ is the first IVDR-certified test to detect minimal residual disease in patients with lymphoid malignancies

SEATTLE, Aug. 29, 2024 (GLOBE NEWSWIRE) — Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial-stage biotechnology company focused on translating the genetics of the adaptive immune system into clinical products for the diagnosis and treatment of disease, today announced that clonoSEQ has received Class C certification under the In Vitro Diagnostic Regulation (IVDR) 2017/746 in the European Union (EU).

The medical diagnostics field has seen significant technological advances in recent years, resulting in the EU replacing its previous regulatory framework, the In Vitro Diagnostics Directive (IVDD), with a more stringent set of quality and safety standards 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. The intended use of clonoSEQ under IVDR is broad in scope, allowing for the assessment of MRD status and changes in disease burden during and after treatment in patients diagnosed with B-cell malignancies.