Bio-Techne Attains European IVDR Certification for Diagnostic Test Monitoring Chronic Myeloid Leukemia

Bio-Techne Corporation (NASDAQ: TECH) has announced today that its Molecular Diagnostics Division, Asuragen, has successfully obtained Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. This certification marks a significant milestone as the kit transitions from being CE-IVD marked under the In Vitro Diagnostic Directive (IVDD) to compliance with the IVDR.

Designed to provide robust and dependable monitoring of chronic myeloid leukemia (CML) patients, the QuantideX qPCR BCR-ABL IS Kit offers a highly sensitive qPCR-based in vitro diagnostic test. It quantifies BCR-ABL1 and ABL1 transcripts in blood samples from CML patients, aiding in the assessment of their response to tyrosine kinase inhibitor (TKI) therapy. Regular monitoring is crucial for CML patients to ensure they receive appropriate treatment, and this kit facilitates direct reporting on the International Scale while simplifying workflow with user-friendly analysis software. Laboratories can efficiently process up to 49 samples per plate, offering a scalable solution.

Matt McManus, President of Bio-Techne’s Diagnostics & Genomics Segment, emphasized the company’s commitment to quality and compliance, welcoming the new IVDR for enhancing safety and performance requirements for diagnostic products. He expressed pride in achieving this certification and reiterated Bio-Techne’s dedication to providing molecular diagnostic and liquid biopsy solutions that offer exceptional performance, scalability, and reliability for laboratory scientists, physicians, and patients.

Bio-Techne Corporation (NASDAQ: TECH) is a leading global life sciences company offering innovative tools and bioactive reagents for the research and clinical diagnostic sectors. Their products support scientific inquiries into biological processes, disease nature, and progression, aiding in drug discovery and enabling accurate clinical tests and diagnoses. With a diverse portfolio of thousands of products, Bio-Techne recorded over $1.1 billion in net sales in fiscal 2023 and employs approximately 3,100 individuals worldwide. For more information about Bio-Techne and its brands, please visit or follow the Company on social media.

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