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

Key Takeaway: Bio-Techne Corporation's Ella platform has received CE-IVD marking, allowing its sale in the European Union. This compact, cartridge-based immunoassay system provides rapid and accurate biomarker results, enhancing clinical workflows. The certification enables European laboratories to utilize Ella for in-house test development and clinical trials, supporting precision medicine initiatives.
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POSITIVE FACTORS

  • Ella platform achieves CE-IVD marking, enhancing access in Europe.
  • Streamlines workflows in clinical laboratories, improving decision-making.
  • Supports a wide range of applications with over 390 analytes.

Full Press Release Details

MINNEAPOLIS,Feb. 16, 2026/PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH), a global provider of life science tools, reagents, and diagnostic products, today announced that the Ella benchtop immunoassay platform has received CE-IVD marking1and is now available for sale in the European Union. This achievement brings Ella's hallmark ease of use, speed and reproducibility to clinical settings, helping laboratories streamline workflows and support timely decision-making.
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 organizations 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 aboutthe Ella CE-IVD markand the Ella platform by visitingbio-techne.com/Ella.
1 CE-IVD marking signifies that a product complies with the European Union's In Vitro Diagnostic Regulation (IVDR, Regulation (EU)2017/746), confirming its safety, performance, and reliability for clinical use.

About Bio-Techne:

Bio-Techne Corporation (NASDAQ:TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With hundreds of thousands of products in its portfolio, Bio-Techne generated over $1.2 billion in net sales in fiscal 2025 and has approximately 3,100 employees worldwide. For more information, visithttps://www.bio-techne.comor follow the Company on social media atLinkedIn,XandYouTube.

Frequently Asked Questions

What is the Ella platform?

The Ella platform is a compact, cartridge-based immunoassay system for rapid biomarker testing.

What does CE-IVD marking signify?

CE-IVD marking indicates compliance with the EU's In Vitro Diagnostic Regulation, ensuring safety and performance.

How does Ella improve clinical workflows?

Ella simplifies traditional immunoassays, reducing operator variability and providing reproducible data.

What applications can use the Ella platform?

Ella supports applications in neuroscience, immunology, oncology, and cell and gene therapy.

Last updated: Feb 16, 2026