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

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

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