San Diego, California — October 29, 2026
Element Biosciences, Inc. announced the commercial launch of AVITI Dx, its first CE-marked in vitro diagnostic (IVD) sequencing platform developed under the European Union’s In Vitro Diagnostic Regulation (EU IVDR). The launch introduces an integrated sequencing solution combining the company’s AVITI™ sequencing system, dedicated reagents and software designed to support regulated clinical laboratory workflows. AVITI Dx is initially available in ten EU countries: the Netherlands, Germany, France, Italy, Spain, Austria, the Czech Republic, Latvia, Romania and Poland. The company plans to expand availability into additional European markets through a phased rollout, followed by selected markets in the Asia-Pacific region. Developed and manufactured under an ISO 13485-certified quality management system, the platform is intended to provide clinical laboratories with sequencing capabilities supported by regulatory-compliant manufacturing controls, software and dedicated diagnostic consumables.
AVITI Dx Combines Sequencing Hardware, Reagents and Software
AVITI Dx integrates the AVITI sequencing instrument with dedicated IVD reagents and software to provide a coordinated solution for clinical laboratory applications. The system is classified as a Class A IVD sequencing system, supported by IVDR-compliant reagents and software. It is built on Element’s proprietary ABC™ chemistry, which also powers the company’s other sequencing solutions. According to Element, the platform combines sequencing performance with flexibility and scalability intended to address the needs of decentralised diagnostics markets. Its integrated design aims to help laboratories operate regulated diagnostic workflows using dedicated system components rather than adapting research-use-only configurations. The launch represents an expansion of Element’s sequencing portfolio into regulated clinical diagnostic markets, where consistent performance, traceability and quality controls are essential. The company highlighted that the platform’s development and manufacturing processes are supported by its established quality management infrastructure, designed to meet the requirements associated with clinical IVD products.
Dual-Boot Design Separates Diagnostic and Research Workflows
A key feature of AVITI Dx is its dual-boot system design, which allows a single sequencing instrument to switch between IVD and research-use-only modes. Dedicated reagents and software maintain separation between regulated diagnostic workflows and research applications. This configuration is intended to provide laboratories with operational flexibility while preserving the distinction between clinical diagnostic use and research activities. The platform’s software interface also supports multiple languages, enabling laboratories to work in the language used in their respective regions. Element said the integrated approach is designed to support the practical needs of clinical laboratories adopting sequencing technologies within regulated environments. The company’s Chief Supply Chain Officer, Jeff Labbadia, stated that the launch reflects years of investment in quality systems, manufacturing capabilities and global supply-chain infrastructure. He also emphasised the importance of consistency, traceability and reliability when delivering sequencing platforms to clinical laboratories. These operational capabilities are particularly relevant as diagnostic laboratories expand the use of sequencing-based technologies within quality-controlled clinical workflows.
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European Launch Supports Element’s Expansion into Clinical Diagnostics
The initial commercial availability of AVITI Dx across ten European countries marks an important step in Element Biosciences’ expansion into the regulated clinical diagnostics market. The company’s ISO 13485-certified quality management system provides the manufacturing and quality-control foundation for the platform, while the IVDR-compliant configuration is intended to support clinical laboratory adoption in the markets where it is being launched. Element plans to extend access to additional European countries before entering selected Asia-Pacific markets. The phased expansion will allow the company to broaden the geographical availability of its diagnostic sequencing platform while building on its existing manufacturing and supply-chain capabilities. AVITI Dx adds a clinical diagnostic offering to Element’s broader technology portfolio, which supports genetic, molecular and cellular research and applications connected to diagnostic and therapeutic development. The launch positions the company to participate more directly in the growing use of sequencing technologies in regulated laboratory settings. Further market expansion and adoption by clinical laboratories will determine the platform’s commercial reach across Europe and other international markets.
Source:Element Biosciences ,Press release
