Twist Bioscience Launches IVDR-compliant Precision Dx Products for Whole Exome Sequencing

Twist 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.

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 our CE-marked Products includes:

• The Twist Precision Prep and Enrichment Dx Kit¹ (Reagents for enzymatic fragmentation, library preparation, and target enrichment), which is panel-agnostic²
• The Twist Precision Exome Dx Panel¹ (Targeted capture probes for exome enrichment)
• Twist Precision Exome Dx Kit¹ (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 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 workflows to enable our customers to seamlessly obtain IVDR certification for their diagnostic tests,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “By taking the steps to have our exome workflow IVDR certified ahead of the transition deadline for existing tests, we continue to support our current customers in Europe developing clinical tests using Twist NGS tools while also expanding our market opportunity to include regulated test workflows. With multiple CE-marked Products, we can support our European customers in several ways, either by providing panel-agnostic library prep and target enrichment for their existing panels, an exome workflow for their existing workflows or a combined solution for an IVDR-compliant workflow.”