Element Biosciences, Inc. 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."