Twist Bioscience Revolutionizes Next-Generation Sequencing with IVDR Compliant Precision Dx Products

07 March 2024 | Thursday | News

Twist Bioscience Corporation (NASDAQ: TWST), a pioneer in synthetic DNA technology, announced today the launch of its next-generation sequencing (NGS) product line, Twist Precision Dx Products. These products have achieved CE marking, affirming their compliance with the European Union’s stringent In Vitro Diagnostic Regulation (IVDR 2017/746) standards, thereby setting a new benchmark in the quality and safety of in vitro diagnostic medical devices.
Image Source | Public Domain

Image Source | Public Domain

 

The newly unveiled suite of Precision Dx Products includes the Twist Precision Prep and Enrichment Dx Kit, the Twist Precision Exome Dx Panel, and the Twist Precision Exome Dx Kit. These products collectively represent a comprehensive solution for whole exome library preparation and target enrichment, tailored to meet the rigorous demands of clinical settings.

Innovative Product Suite Designed for Precision Diagnostics

The Twist Precision Dx lineup is engineered to facilitate panel sequencing within clinical environments, offering a versatile range of applications:

  • Twist Precision Prep and Enrichment Dx Kit: Provides reagents for enzymatic fragmentation, library preparation, and target enrichment, designed to be panel-agnostic.
  • Twist Precision Exome Dx Panel: Comprises targeted capture probes for exome enrichment, expanding coverage to include the mitochondrial genome and additional clinically relevant loci.
  • Twist Precision Exome Dx Kit: Combines the capabilities of the Prep and Enrichment Kit with the Exome Dx Panel for a fully integrated IVDR-compliant workflow for exome enrichment.

These products can be utilized independently or in conjunction to offer a tailored solution for genomic diagnostics, further enhanced by Twist’s collaboration with Platomics. This partnership aims to streamline the regulatory documentation and compliance process for laboratories utilizing the Twist Precision Exome Dx Kit, thereby accelerating the adoption of advanced diagnostic tests across Europe.

A Leap Forward for Clinical Diagnostics

Dr. Emily M. Leproust, CEO and co-founder of Twist Bioscience, expressed her enthusiasm about the launch: “The introduction of the Twist Precision Dx products marks a significant milestone in our mission to empower our customers with cutting-edge genomic tools. As the first NGS product line from Twist designed specifically for regulated customer products, it underscores our commitment to advancing clinical diagnostics and personalized medicine.”

The Precision Dx Products are distinguished by their ability to provide comprehensive coverage of over 98% of target bases at 30x depth, coupled with a reliable and uniform enrichment process. This ensures high-quality genomic DNA sequencing from human samples, facilitating accurate and efficient diagnostic processes.

With the IVDR certification, Twist Bioscience is well-positioned to support the evolving needs of its European customer base, offering a scalable solution that addresses both current and future challenges in the rapidly advancing field of genomic diagnostics.

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