Bio-Techne has announced that the Ella benchtop immunoassay platform has received CE-IVD marking and is now available for sale in the European Union.
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 organisations 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 platform by visiting www.bio-techne.com/Ella.