Bio‑Techne Corporation announced that its Ella benchtop immunoassay platform has received CE‑IVD marking, a regulatory approval that authorizes the cartridge‑based system for use in European clinical laboratories. The CE‑IVD certification confirms that Ella meets the European Union’s In‑Vitro Diagnostic Regulation (IVDR) requirements for safety, performance and reliability, enabling hospitals and diagnostic labs to adopt the platform for rapid, reproducible biomarker testing.
Ella is a cartridge‑based system that can multiplex up to eight analytes in under 90 minutes, requires minimal hands‑on time, and uses only 25 µL of sample. The platform is compatible with Simple Plex assays, which are currently for research use only but are powered by R&D Systems antibodies and proteins. These technical attributes position Ella as a fast, low‑volume solution for clinical laboratories that need timely results.
The CE‑IVD marking expands Bio‑Techne’s commercial footprint in Europe and supports its precision‑diagnostics strategy. It opens a new revenue channel for the company’s high‑margin immunoassay solutions, a timely development given that Q2 FY2026 revenue was flat year‑over‑year at $295.9 million. The approval also aligns with the company’s broader effort to meet evolving European regulatory standards, following earlier IVDR certifications for its R&D Systems Hematology Controls and Calibrators and its Asuragen QuantideX® qPCR BCR‑ABL IS Kit.
Will Geist, President of Bio‑Techne’s Protein Sciences Segment, said, "Ella's CE‑IVD certification marks a significant step forward in advancing precision diagnostics. It reflects our commitment to providing innovative tools that enhance clinical decision‑making and improve patient outcomes."
Prior to this announcement, Bio‑Techne had already achieved IVDR compliance for several other products and is divesting its Exosome Diagnostics business to focus on core growth areas. The new certification positions Ella as a key component of the company’s diagnostics portfolio and underscores its strategy to deliver standardized, high‑performance biomarker detection tools across global markets.
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