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Twist Bioscience Unveils Precision Dx Products, Compliant with EU IVDR, for Comprehensive Whole Exome Sequencing

NextEdge Admin

06 Mar 2024

2 min 47 sec

Twist Bioscience Corporation has announced the launch of its Twist Precision Dx next-generation sequencing (NGS) Products, which comply with the European Union (EU) in vitro diagnostic regulations (IVDR). These products are CE-marked, demonstrating their adherence to the EU IVDR 2017/746 regulations, ensuring safety and quality in in vitro diagnostic medical devices. The Precision Dx product suite includes the Twist Precision Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel, and Twist Precision Exome Dx Kit.

The Twist Precision Prep and Enrichment Dx Kit is a reagent kit facilitating enzymatic fragmentation, library preparation, and targeted capture, suitable for panel-agnostic applications. The Twist Precision Exome Dx Panel, a qualified DNA panel, can be used with the Prep and Enrichment Dx Kit to generate exome-enriched libraries for NGS applications. The Twist Precision Exome Dx Kit combines the Twist Precision Exome Dx Panel with the Prep and Enrichment Dx Kit, offering an integrated solution for exome-enriched libraries.

Twist Bioscience is collaborating with Platomics to streamline documentation generation on Platomics’ platform, aiding laboratories in incorporating Twist Precision Exome Dx Kit workflows and automating regulatory processes for compliance.

Emily M. Leproust, CEO and co-founder of Twist Bioscience, highlighted that the Precision Dx products are the company’s first NGS product line developed for regulated customer products. The Precision Dx workflow offers extensive coverage, reliable performance, and flexibility, supporting laboratories in obtaining IVDR certification for diagnostic tests within the European market.

Twist Bioscience is a synthetic biology and genomics company with a disruptive DNA synthesis platform, catering to various industries, including healthcare, industrial chemicals, agriculture, and academic research. The company’s products include synthetic genes, tools for next-generation sequencing preparation, and antibody libraries for drug discovery.