Bio-Techne Receives EU IVDR for QuantideX® qPCR BCR-ABL IS Kit

Asuragen, part of Bio-Techne‘s Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit, providing labs with a robust and reliable tool for monitoring chronic myeloid leukemia (CML) patients.

The highly sensitive qPCR-based in vitro diagnostic test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from CML patients to determine their response to tyrosine kinase inhibitor (TKI) therapy. CML patients must undergo regular monitoring to ensure that they continue to receive the most appropriate treatment for their cancer.

The QuantideX kit, which has been CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), enables direct reporting on the International Scale and further streamlines the workflow with easy-to-use analysis software. Clinical lab scientists can run up to 49 samples per plate for a scalable solution.

We are proud to achieve this new certification and will continue to provide the molecular diagnostic and liquid biopsy solutions that deliver world-class performance, scalability, and reliable results for the laboratory scientists, physicians, and patients who count on us,” said Matt McManus, President of Bio-Techne‘s Diagnostics & Genomics Segment.

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