NEW YORK – Adaptive Biotechnologies said Thursday that it has received European In Vitro Diagnostic Medical Device Regulation (IVDR) Class C certification for its ClonoSeq assay.
With the certification, European clinical labs can now offer the ClonoSeq assay to patients with lymphoid malignancies for the detection of minimal residual disease (MRD), Seattle-based Adaptive said.
Additionally, the IVDR designation allows Adaptive to meet the clinical trial regulations for testing EU subjects' samples, enabling customers to send clinical samples from the EU to Adaptive's laboratory in Seattle, according to the company.
Adaptive previously obtained the CE mark for ClonoSeq under the EU's old In Vitro Diagnostics Directive (IVDD) framework, and the company worked with EU notified body BSI to transition ClonoSeq from IVDD to IVDR.
Most molecular devices are regulated in the EU under Class C within the new IVDR framework. Class C covers in vitro diagnostic devices that represent a medium to high risk to the general population but lesser risk than Class D devices.
"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," Susan Bobulsky, Adaptive's chief commercial officer for MRD, said in a statement.