The CE-IVD marked system will enable diagnostic pathologists with new applications
MINNEAPOLIS — Bio-Techne (NASDAQ:TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities and Leica Biosystems, a global leader in workflow solutions and automation, are proud to announce the European launch of the CE-IVD marked RNAscope™ In Situ Hybridization Detection Kit for automation on the BOND-III platform. The combination of Bio-Techne’s RNAscope and Leica’s BOND-III will provide pathologists access to an unprecedented number of leading applications to support their diagnostics labs.
Tissue-based diagnostics are growing in globally and there is a demand for high throughput, streamlined workflows that enable visualization of genomic expression at the individual cell level. RNAscope, a leading RNA ISH technology, improves on traditional ISH methodologies through higher target sensitivity and specificity. This combined with the automation of the Leica BOND-III, will optimize and streamline the applications in diagnostic labs.
“We are excited to expand our Leica partnership with the launch of our CE-IVD marked detection kit in Europe. Diagnostic labs will now have access to the fully automated RNAscope technology, providing pathologists with a powerful new tool to evaluate biomarkers involved in cancer, infection, and other important human diseases,” said Kim Kelderman, President, Diagnostics and Genomics Segment of Bio-Techne.
“During these difficult times and ever-changing world due to COVID-19, we are excited about this innovative product as it delivers the benefit of improved workflow, reduced hands on time and provides our European pathology partners an additional tool in their IVD tool box against various diseases,” said Colin White, Global Vice President, Advanced Staining and Imaging at Leica Biosystems.
The RNAscope In Situ Hybridization Detection Kit and Probes are a robust technology that identifies RNA expression patterns and localization at the single cell level with spatial and morphologic context. The RNAscope technology is highly sensitive, and specific due to its double Z probe design, resulting in an extremely high signal-to-noise ratio of staining in various tissues types, allowing diagnostic pathologists to visualize, localize, and quantify biomarker expression simultaneously.
Building on its legacy of excellence in advanced staining technology and pathology processes the new BOND-III makes it easier for labs to quickly and consistently deliver complete cases to pathologists. With optimal patient care depending on an accurate and timely diagnosis, the latest advance to the BOND-III stainer incorporates a unique set of productivity innovations to support pathology labs’ drive for procedural efficiency and diagnostic confidence.
About Bio-Techne
Bio-Techne Corporation (NASDAQ: TECH) is a leading developer and manufacturer of high-quality purified proteins and reagent solutions – notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, T-Cell activation and gene editing technologies. Bio-Techne’s product portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name, offering researchers efficient and streamlined options for automated Western blot and multiplexed ELISA workflow. These reagent and protein analysis solutions are sold to biomedical researchers as well as clinical research laboratories and constitute the Protein Sciences Segment. Bio-Techne also develops and manufactures diagnostic products including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls and custom assay development on dedicated clinical instruments. Bio-Techne’s genomic tools include advanced tissue-based in situ hybridization assays (ISH) for research and clinical use, sold under the ACD brand as well as a portfolio of clinical molecular diagnostic oncology assays, including the ExoDx® Prostate test for prostate cancer diagnosis. These diagnostic and genomic products comprise Bio-Techne’s Diagnostics and Genomics Segment. Bio-Techne products are integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression 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 approximately $714 million in net sales in fiscal 2019 and has over 2,200 employees worldwide.
About Leica Biosystems
Leica Biosystems (LeicaBiosystems.com) is a global leader in workflow solutions and automation, integrating each step in the workflow. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries and is headquartered in Nussloch, Germany.