MINNEAPOLIS - Bio-Techne (NASDAQ:TECH) Corporation (NASDAQ: TECH) has announced that its Asuragen division has successfully achieved Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for the QuantideX® qPCR BCR-ABL IS Kit. This certification indicates compliance with the latest European diagnostic standards, replacing the previous In Vitro Diagnostic Directive (IVDD) under which the kit was CE-IVD marked.
The QuantideX qPCR BCR-ABL IS Kit is a diagnostic tool used by laboratories to monitor patients with chronic myeloid leukemia (CML). It quantifies BCR-ABL1 and ABL1 transcripts in blood samples, which is essential for determining patients' responses to tyrosine kinase inhibitor (TKI) therapy.
Regular patient monitoring is crucial for ensuring the effectiveness of their treatment regimen. The kit offers a scalable solution, capable of running up to 49 samples per plate, and includes user-friendly analysis software for streamlined laboratory workflow.
Matt McManus, President of Bio-Techne's Diagnostics & Genomics Segment, stated, "Bio-Techne is dedicated to quality and compliance, and we applaud this new IVDR for strengthening the safety and performance requirements for diagnostic products." He further emphasized the company's commitment to providing reliable molecular diagnostic and liquid biopsy solutions.
Bio-Techne is a global life sciences company that offers a variety of tools and bioactive reagents for research and clinical diagnostic communities. Their products support scientific research, drug discovery, and clinical diagnosis. The company reported over $1.1 billion in net sales for fiscal 2023 and employs approximately 3,100 people internationally.
The information for this article is based on a press release statement from Bio-Techne Corporation.
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