Bio-Techne's Ella Platform Achieves CE-IVD Marking, Expanding Access to Rapid Immunoassays in EU Clinical Labs

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Bio-Techne's Ella benchtop immunoassay platform received CE-IVD marking on February 16, 2026, and is now available for sale in the European Union.124

The certification complies with EU In Vitro Diagnostic Regulation (IVDR), confirming safety, performance, and reliability for clinical use.24

Ella delivers biomarker results in under 90 minutes with minimal hands-on time, reducing operator variability and improving reproducibility.12

Compatible with Simple Plex assays covering over 390 analytes in neuroscience, immunology, and oncology.1

Enables hospitals, clinical labs, and diagnostic developers in Europe to use Ella for in-house test development, clinical trials, and translational activities.234

Supports Bio-Techne's goals in precision medicine by standardizing biomarker detection and enhancing clinical decision-making.12

Sources:

1. https://intellectia.ai/news/stock/biotechnes-ella-platform-receives-ceivd-marking

2. https://investors.bio-techne.com/press-releases/detail/526/bio-technes-ella-platform-achieves-ce-ivd-marking

3. https://www.nasdaq.com/articles/bio-technes-ella-immunoassay-platform-receives-ce-ivd-marking-eu

4. https://www.prnewswire.com/news-releases/bio-technes-ella-platform-achieves-ce-ivd-marking-expanding-access-to-rapid-cartridgebased-immunoassays-for-european-clinical-laboratories-302688454.html