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Bio-Techne, Leica Biosystems Receive CE Mark for Pathology Detection Kit, Platform

NEW YORK ─ Bio-Techne and Leica Biosystems said Tuesday that they have received the CE mark for Bio-Techne's RNAscope In Situ Hybridization Detection Kit for automation on the Leica Biosystems Bond-III staining platform.

They have launched the product in Europe.

The combination of Bio-Techne's RNAscope and Leica's Bond-III stainer will provide pathologists with access to leading applications to support their diagnostics labs, the firms said.

Kim Kelderman, president of the diagnostics and genomics segment of Minneapolis, Minnesota-based Bio-Techne, said in a statement that 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."

The life sciences firm's RNAscope In Situ Hybridization Detection Kit and probes identify RNA expression patterns and localization at the single-cell level with spatial and morphologic context.

RNAscope technology is highly sensitive and specific due to its double Z-probe design, resulting in a high signal-to-noise ratio of staining in various tissues types and allowing diagnostic pathologists to simultaneously visualize, localize, and quantify biomarker expression, they added.

The new Bond-III stainer, developed by Wetzlar, Germany-based Leica Biosystems, a division of Danaher, makes it easier for labs to quickly deliver complete cases to pathologists, the firms said. The latest advance to the Bond-III stainer incorporates a set of productivity innovations to support pathology labs' drive for procedural efficiency and diagnostic confidence, they added.