BIO-TECHNE RECEIVES EUROPEAN IVDR CERTIFICATION FOR DIAGNOSTIC TEST TO MONITOR CHRONIC MYELOID LEUKEMIA

Rhea-AI Summary

Bio-Techne's QuantideX qPCR BCR-ABL IS Kit is now compliant with the latest EU diagnostic regulations, enhancing monitoring for CML patients. The kit offers robust quantification of BCR-ABL1 and ABL1 transcripts, aiding in TKI therapy response assessment.

Positive

• The QuantideX qPCR BCR-ABL IS Kit is now compliant with the new EU IVDR regulations.
• The kit provides a reliable tool for monitoring CML patients and assessing their response to TKI therapy.
• It allows for direct reporting on the International Scale and offers easy-to-use analysis software for streamlined workflow.
• Bio-Techne emphasizes quality and compliance, aiming to deliver world-class performance and reliable results for laboratory scientists, physicians, and patients.

Negative

• None.

Medical Research Analyst

The recent certification of the QuantideX qPCR BCR-ABL IS Kit under the European Union In Vitro Diagnostic Regulation (IVDR) represents a significant compliance milestone for Bio-Techne Corporation. This adaptation to the new regulatory framework ensures that their product continues to be available in the European market without any legal or commercial interruptions. From a research perspective, the compliance with IVDR, which demands higher safety and performance standards, can be seen as a testament to the kit's reliability and efficacy in monitoring chronic myeloid leukemia (CML) patients.

The technical robustness of the QuantideX kit, which allows for the quantification of BCR-ABL1 and ABL1 transcripts, is important for the personalized treatment plans of CML patients. This is because the therapeutic response to tyrosine kinase inhibitor (TKI) therapy can vary significantly among individuals. Ensuring that the kit meets the highest standards could potentially lead to improved patient outcomes by facilitating more accurate monitoring and, consequently, more precise adjustments to therapy regimes.

Healthcare Industry Analyst

From an industry standpoint, Bio-Techne's achievement in obtaining Class C Certification under the IVDR for their QuantideX qPCR BCR-ABL IS Kit is a strategic move that could strengthen their position in the European molecular diagnostics market. The IVDR's stringent requirements for diagnostic products may pose challenges for some manufacturers, potentially leading to market consolidation. Bio-Techne's proactive compliance could therefore provide a competitive advantage, as it may increase the trust of healthcare providers and patients in their products.

Moreover, the scalability and ease of use of the QuantideX kit, as highlighted by the inclusion of analysis software and the capacity to run up to 49 samples per plate, align with the growing demand for efficient diagnostic solutions in clinical laboratories. This efficiency could translate into cost savings and faster turnaround times, which are key factors in the decision-making process for lab equipment procurement.

Market Research Analyst

For investors and stakeholders, the announcement of the QuantideX kit's compliance with IVDR is an indicator of Bio-Techne's commitment to maintaining market access and expanding their product offerings in the diagnostics space. As regulatory landscapes evolve, companies that can quickly adapt and meet new standards are likely to experience less disruption to their sales and may even capture additional market share from less agile competitors. This certification may also signal to investors that Bio-Techne is well-positioned to navigate future regulatory changes, which could have positive implications for long-term growth and stability.

It's important to note that the molecular diagnostics market is rapidly growing, driven by the increasing prevalence of personalized medicine and the need for precise diagnostic tools. The certification of the QuantideX kit aligns with these market trends and could bolster investor confidence in Bio-Techne's growth trajectory within this sector.

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

View original content to download multimedia:https://www.prnewswire.com/news-releases/bio-techne-receives-european-ivdr-certification-for-diagnostic-test-to-monitor-chronic-myeloid-leukemia-302096618.html

SOURCE Bio-Techne Corporation

What is the significance of the QuantideX qPCR BCR-ABL IS Kit being compliant with the latest EU diagnostic regulations?

The compliance with the new EU IVDR regulations ensures that the kit meets the latest safety and performance requirements for diagnostic products, enhancing its reliability and quality.

How does the QuantideX qPCR BCR-ABL IS Kit aid in monitoring CML patients?

The kit quantifies BCR-ABL1 and ABL1 transcripts in blood samples from CML patients to determine their response to TKI therapy, allowing for regular monitoring to ensure appropriate treatment.

What benefits does the QuantideX qPCR BCR-ABL IS Kit offer to clinical lab scientists?

The kit allows for direct reporting on the International Scale, streamlines workflow with easy-to-use analysis software, and enables running up to 49 samples per plate for a scalable solution.

Who commented on Bio-Techne's achievement of the new IVDR certification?

Matt McManus, President of Bio-Techne's Diagnostics & Genomics Segment, highlighted the company's dedication to quality and compliance, emphasizing the importance of the new IVDR for strengthening safety and performance requirements.