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- Ella benchtop instrument is now CE-IVD marked and available for sale in the EU
- Enables diagnostic assay developers to leverage a simplified platform that delivers speed and reproducible results with minimal hands-on time
- Provides confidence for use in clinical trials and in-house test development
Bio-Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents, and diagnostic products, today announced that the Ella benchtop immunoassay platform has received CE-IVD marking1 and is now available for sale in the European Union. This achievement brings Ella's hallmark ease of use, speed and reproducibility to clinical settings, helping laboratories streamline workflows and support timely decision-making.
Ella is a compact, cartridge-based immunoassay system that delivers accurate biomarker results in under 90 minutes with minimal hands-on time. By simplifying the manual steps of traditional immunoassays, Ella reduces operator variability and provides high-quality, reproducible data suitable for both translational research and clinical applications.
The platform is compatible with Simple Plex™ assays, which remain for research use only, and are powered by R&D Systems antibodies and proteins. With more than 390 analytes across neuroscience, immunology, oncology, and cell and gene therapy, the Simple Plex portfolio enables researchers to maintain consistency and data quality while working efficiently across a wide range of applications.
"Ella's CE-IVD certification marks a significant step forward in advancing precision diagnostics," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "It reflects our commitment to providing innovative tools that enhance clinical decision-making and improve patient outcomes."
With CE-IVD marking now in place, hospitals, clinical laboratories, or other European organizations may use Ella as a validated platform for in-house test development, clinical trials, or other translational activities. Diagnostic assay developers may also develop clinical applications on the Ella CE-IVD validated platform. The certification enhances confidence in Ella's performance and supports Bio-Techne's long-term goal to advance precision medicine by providing dependable, standardized solutions for biomarker detection.
Learn more about the Ella CE-IVD mark and the Ella platform by visiting Bio-Techne.com/Ella.
1 CE-IVD marking signifies that a product complies with the European Union's In Vitro Diagnostic Regulation (IVDR, Regulation (EU)2017/746), confirming its safety, performance, and reliability for clinical use.
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 hundreds of thousands of products in its portfolio, Bio-Techne generated over $1.2 billion in net sales in fiscal 2025 and has approximately 3,100 employees worldwide. For more information, visit https://www.bio-techne.com or follow the Company on social media at LinkedIn, X and YouTube.
Media Contacts:
Corporate Communications
media.relations@bio-techne.com
David Clair, Vice President, Investor Relations
IR@bio-techne.com
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SOURCE Bio-Techne Corporation
