Element Biosciences Launches AVITI Dx™, Bringing CE-Marked IVD Sequencing to Ten EU Countries

Integrated sequencing, reagents, and software bring IVDR-compliant sequencing capabilities to European clinical laboratories, with additional global markets planned to follow

SAN DIEGO--(BUSINESS WIRE)--Element Biosciences, Inc. today announced the commercial launch of AVITI Dx, the company's first CE-marked in vitro diagnostic (IVD) sequencing platform under the European Union's In Vitro Diagnostic Regulation (EU IVDR). AVITI Dx integrates Element’s AVITI™ sequencing system, dedicated reagents, and software designed to meet applicable IVDR requirements and support regulated clinical laboratory workflows. The system is launching commercially in ten EU countries: the Netherlands, Germany, France, Italy, Spain, Austria, the Czech Republic, Latvia, Romania, and Poland, with additional markets planned through a phased approach.

Developed and manufactured under Element's ISO 13485-certified quality management system, AVITI Dx is a Class A IVD sequencing system supported by IVDR-compliant reagents and software. Built on the same industry-leading ABC™ chemistry that powers Element's other solutions, AVITI Dx delivers the high-quality performance AVITI is known for, with the flexibility and scalability that the decentralized diagnostics market needs. A dual-boot design lets a single system switch between IVD and research use only modes, with dedicated reagents and software keeping IVD workflows separate from research applications. The AVITI Dx software interface supports multiple languages, so laboratories can work in the language of their region.

“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,” said Jeff Labbadia, Chief Supply Chain Officer at Element Biosciences. “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."

Element plans to expand access to AVITI Dx in additional European markets, followed by select markets in the Asia-Pacific region. Contact us to learn more about AVITI Dx link.

About Element Biosciences, Inc.

Element Biosciences is pioneering the technologies that enable a deeper understanding of life. Our platforms capture biology in its full dimensionality—spanning genetic, molecular, and cellular insights—to unlock richer data and drive scientific breakthroughs. From foundational research, to the discoveries that help shape diagnostic and therapeutic development, Element empowers scientists to advance the frontiers of biology and impact every corner of human health. To learn more about Element, please visit www.elementbiosciences.com and follow us on LinkedIn, X (Twitter), Bluesky and Facebook.