Illumina DNA Prep with Enrichment Dx

A library preparation and enrichment solution for IVD targeted sequencing applications.

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Overview

Illumina DNA Prep with Enrichment Dx enables clinical labs to add targeted sequencing enrichment panels to their diagnostic applications and is an approved IVD medical device in the United States, the European Union, the United Kingdom, and other international markets.

This FDA-registered and EU IVDR 2017/746–compliant library prep and enrichment kit enables clinical labs to add targeted sequencing enrichment panels to their diagnostic applications.

  • Essential component for building a targeted NGS IVD assay on Illumina Dx instruments

  • Flexible support for various sizes of fixed and custom panels, including exome panels

  • Compatibility with Illumina and third-party enrichment DNA probe panels 

  • Streamlined workflow enables smooth transition to assay development and implementation

Optimized performance

The kit is compatible with FDA-registered and CE-marked IVD NGS platforms that use proven sequencing by synthesis (SBS) chemistry to deliver highly accurate diagnostic testing. 

Integrated software

Local Run Manager in Dx mode offers onboard primary analysis with a user-friendly interface on the MiSeqDx or NextSeq 550Dx instruments. The DRAGEN for Illumina DNA Prep with Enrichment Dx App performs alignment and variant calling in DNA for somatic and germline mutations. This app automatically launches secondary analysis when paired with an On-Premise DRAGEN Server and the NextSeq 550Dx or NovaSeq 6000Dx instruments via Illumina Run Manager.  

Intended use

Intended use (CE-marked IVD) 

Illumina DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from genomic DNA derived from human cells and tissue to develop in vitro diagnostic assays. User supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina sequencing systems. The Illumina DNA Prep with Enrichment Dx includes software for sequencing run setup, monitoring, and analysis.

Intended use (FDA-registered) 

Illumina DNA Prep with Enrichment Dx is a set of reagents and consumables used to prepare sample libraries from genomic DNA derived from human cells and tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina sequencing systems.

Specifications

Required products

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FAQs

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Speak with a specialist

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