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

Core Insights - Bio-Techne Corporation's Ella benchtop immunoassay platform has received CE-IVD marking, allowing it to be sold in the European Union, which enhances its usability in clinical settings [1][1][1] Product Features - The Ella platform is a compact, cartridge-based immunoassay system that provides accurate biomarker results in under 90 minutes with minimal hands-on time, reducing operator variability and ensuring high-quality, reproducible data [1][1][1] - It is compatible with Simple Plex™ assays, which are for research use only, and includes over 390 analytes across various fields such as neuroscience, immunology, oncology, and cell and gene therapy [1][1][1] Strategic Importance - The CE-IVD certification signifies compliance with the European Union's In Vitro Diagnostic Regulation, confirming the platform's safety, performance, and reliability for clinical use [1][1][1] - This certification allows hospitals and clinical laboratories in Europe to utilize Ella for in-house test development and clinical trials, supporting Bio-Techne's goal of advancing precision medicine [1][1][1] Company Overview - Bio-Techne Corporation generated over $1.2 billion in net sales in fiscal 2025 and employs approximately 3,100 people globally, providing innovative tools and bioactive reagents for research and clinical diagnostics [1][1][1]