Bio-Techne Corporation has received CE-IVD marking for its Ella benchtop immunoassay platform, enabling commercial availability across the European Union and opening new opportunities for clinical diagnostic use.

Ella is a compact, cartridge-based immunoassay system designed to deliver precise biomarker measurements in under 90 minutes with minimal operator involvement. By automating many steps associated with conventional immunoassays, the platform reduces variability and produces consistent, high-quality data suited for translational and clinical workflows.

The system supports Simple Plex assays, which remain designated for research use, and are powered by antibodies and proteins from R&D Systems. With a portfolio covering more than 390 analytes spanning neuroscience, immunology, oncology, and cell and gene therapy, the platform enables researchers to maintain data consistency while improving laboratory efficiency.

Company leadership described the CE-IVD milestone as a major advancement in precision diagnostics, reinforcing the firm’s focus on developing technologies that support faster clinical decisions and improved patient outcomes.

With the certification in place, hospitals, clinical laboratories, and diagnostic developers across Europe can use Ella as a validated platform for in-house assay development, clinical trials, and other translational applications. The approval strengthens confidence in the platform’s performance and aligns with the company’s broader strategy to advance standardized biomarker testing solutions for clinical and research environments.