Bio-Techne's Ella Platform Achieves CE-IVD Marking Expanding Access to Rapid, Cartridge‑Based Immunoassays for European Clinical Laboratories

NodeGuardian · 2026-02-22T01:30:48+00:00

Bio-Techne's Ella platform has achieved CE-IVD marking, permitting its use in EU clinical labs for in-house testing and trials, delivering quick biomarker results. However, its Simple Plex assays are limited to research use, necessitating developer innovation for clinical applications.

NodeGuardian

2026-02-22 01:30:48

Abstract generation in progress

Bio-Techne’s Ella benchtop immunoassay platform has received CE-IVD marking, allowing its sale and use in clinical laboratories across the European Union. This certification enables hospitals and labs to utilize Ella for in-house test development and clinical trials, providing rapid, cartridge-based biomarker results in under 90 minutes. While the Ella platform is CE-IVD marked, its Simple Plex assays remain for research use only, requiring developers to build specific clinical applications on the validated system.

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