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Twist Bioscience Launches IVDR-compliant Precision Dx Products for Whole Exome Sequencing
Precision Dx Products are CE-marked and compliant with EU IVDR 2017/746 regulations Precision Dx Products include Twist Precision Prep and Enrichment Dx Kit,
About this update from Twist Bioscience Corporation
[{"type":"text","content":"\nPrecision Dx Products are CE-marked and compliant with EU IVDR 2017/746 regulations\n\n\nPrecision Dx Products include Twist Precision Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel and Twist Precision Exome Dx Kit\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nTwist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced European Union (EU) in vitro diagnostic regulations (IVDR) compliant Twist Precision Dx next-generation sequencing (NGS) Products.\n\n\nIn accordance with the IVD regulations put in place by the EU to ensure the safety and quality of in vitro diagnostic medical devices, Twist’s Precision Dx Products are CE-marked and compliant with EU IVDR 2017/746 regulations demonstrating the quality of kit materials. The Precision Dx products are designed to enable panel sequencing within a clinical setting.\n\n\nThe suite of our CE-marked Products includes:\n\n\n\nThe Twist Precision Prep and Enrichment Dx Kit1 (Reagents for enzymatic fragmentation, library preparation, and target enrichment), which is panel-agnostic2\n\n\n\nThe Twist Precision Exome Dx Panel1 (Targeted capture probes for exome enrichment)\n\n\n\nTwist Precision Exome Dx Kit1 (Reagents for enzymatic fragmentation, library preparation, and target enrichment along with targeted capture probes for exome enrichment; IVDR compliant workflow)\n\n\n\nThe Twist Precision Prep and Enrichment Dx Kit and the Twist Precision Exome Dx Panel can be used individually within existing workflows or as a combined solution known as the Twist Precision Exome Dx Kit. In addition, as an added service to customers, Twist is collaborating with Platomics to enable laboratories to efficiently generate documentation on Platomics’ multi-stakeholder platform for workflows incorporating the Twist Precision Exome Dx Kit, and to help automate regulatory processes and accelerate compliance for laboratories and manufacturers.\n\n\n“The Twist Precision Dx products are our first NGS product line specifically developed to be included within regulated customer products. With IVD regulation in place and an expanding customer base in EMEA, we’ve launched one of the first comprehensive, fully-validated whole exome library preparation and target enrichment workfl...