Twist Bioscience Corporation announced European Union (EU) in vitro diagnostic regulations (IVDR) compliant Twist Precision Dx next-generation sequencing (NGS) Products. In 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.

The suite of the company's CE-marked Products includes: The Twist Precision Prep and Enrichment Dx Kit (Reagents for enzymatic fragmentation, library preparation, and target enrichment), which is panel-agnostic. The Twist Precision Exome Dx Panel (Targeted capture probes for exome enrichment). Twist Precision Exome Dx Kit (Reagents for enzymatic fragmentation, library preparation, and target enrichment along with targeted capture probes for exome enrichment; IVDR compliant workflow).

The 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.

The Precision Dx workflow enables comprehensive coverage with more than 98% of target bases covered at 30x as well as reliable performance with uniform enrichment and consistent yield from high-complexity libraries. The Precision Dx Products are intended for use with high-quality genomic DNA derived from human cells and allow for flexibility within workflows.