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Element Biosciences Launches AVITI Dx in Ten EU Countries, Scipher PrismTcell, Deep Breathe FDA Clearance — Oct 29, 2026
The Diagnostics & Lab Testing Business Brief — Thursday, October 29, 2026
The business behind the tests. Today's developments shaping the diagnostics industry.
Element Biosciences launches AVITI Dx™ in ten EU countries: announced Oct 29, 2026 — the company's first CE-marked in vitro diagnostic (IVD) sequencing platform under the EU IVDR; Class A IVD system integrating the AVITI™ sequencer, dedicated reagents, and software under an ISO 13485-certified quality management system; dual-boot design switches between IVD and research-use-only modes; launching in the Netherlands, Germany, France…
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