The QuantideX® qPCR BCR-ABL IS Kit
is now compliant with the latest diagnostic regulations in
Europe
MINNEAPOLIS, March 22,
2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:
TECH) today announced that 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. Previously, the
kit was CE-IVD marked for sale in the EU in compliance with the In
Vitro Diagnostic Directive (IVDD), which has now been replaced
by the IVDR.
The QuantideX qPCR BCR-ABL IS Kit gives labs 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
patients with CML 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 allows
for 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.
"Bio-Techne is dedicated to quality and compliance, and we
applaud this new IVDR for strengthening the safety and performance
requirements for diagnostic products," said Matt McManus, President of Bio-Techne's
Diagnostics & Genomics Segment. "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."
About Bio-Techne:
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences
company providing innovative tools and bioactive reagents for the
research and clinical diagnostic communities. Bio-Techne products
assist scientific investigations into biological processes and the
nature and progress of specific diseases. They aid in drug
discovery efforts and provide the means for accurate clinical tests
and diagnoses. With thousands of products in its portfolio,
Bio-Techne generated over $1.1
billion in net sales in fiscal 2023 and has approximately
3,100 employees worldwide. For more information on Bio-Techne and
its brands, please visit https://www.bio-techne.com or
follow the Company on social media
at: Facebook, LinkedIn, Twitter or YouTube.
Contact:
David Clair, Vice President,
Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416
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SOURCE Bio-Techne Corporation