CE-Marked IVD Sequencing Platform Launches Across Ten EU Countries

In Europe, meeting applicable EU IVDR requirements also means maintaining consistency, traceability, and reliability across decentralized diagnostic settings. To support these needs, a newly launched platform brings CE-marked IVD sequencing capabilities to clinical laboratories in ten EU countries through integrated instrumentation, reagents, and software.

Element Biosciences, Inc. (San Diego, CA, USA) has commercially launched AVITI Dx, its first CE-marked in vitro diagnostic (IVD) sequencing platform under the European Union’s In Vitro Diagnostic Regulation (EU IVDR). The platform combines Element’s AVITI sequencing system with dedicated reagents and software designed to meet applicable IVDR requirements. The commercial launch spans the Netherlands, Germany, France, Italy, Spain, Austria, the Czech Republic, Latvia, Romania, and Poland.

Developed and manufactured under Element’s ISO 13485-certified quality management system, AVITI Dx is a Class A IVD sequencing system designed to support regulated clinical laboratory workflows. It uses the same chemistry that powers Element’s other solutions, with a dual-boot configuration that allows a single instrument to switch between IVD and research use only (RUO) modes. Dedicated reagents and software maintain separation between diagnostic workflows and research applications.

To support use across these markets, the AVITI Dx software interface offers multiple languages, allowing laboratories to operate in their regional language. Together with IVDR-compliant reagents and software, this configuration is intended to provide flexibility and scalability for decentralized diagnostic settings. Element plans to extend access through a phased expansion into additional European markets, followed by select Asia-Pacific markets.

 “Launching AVITI Dx across ten EU markets reflects years of investment in the quality systems, manufacturing capabilities, and global supply chain needed to support regulated clinical markets. Our ISO 13485-certified quality management system and established manufacturing controls provide the foundation for delivering an integrated sequencing platform with the consistency, traceability, and reliability that clinical laboratories expect,” said Jeff Labbadia, Chief Supply Chain Officer at Element Biosciences.

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