When used in diagnostic mode on the NextSeq 550Dx, Illumina DNA Prep with Enrichment Dx supports user-supplied probe panels that meet the required specifications, including fixed and custom panels of varying sizes.
NextSeq 550Dx Instrument applications and methods
Supporting IVD testing and clinical research
Perform and develop diagnostic assays and fuel clinical research applications with sequencing and array scanning on one instrument
Key diagnostic applications
Library prep
Illumina DNA Prep with Enrichment Dx
An FDA-regulated and IVDR-compliant library preparation and enrichment solution for in vitro diagnostic (IVD) targeted sequencing applications.
Sequence
NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles)
Sequencing reagents offering a simplified workflow and high data quality for in vitro diagnostic (IVD) testing.
Analyze
Integrated-on instrument solution for creating a sequencing run, monitoring run status, analyzing sequencing data, and viewing results.
Illumina DNA Prep with Enrichment Dx App with DRAGEN Server for NextSeq 550Dx*
The DRAGEN server features an integrated Field Programmable Gate Array (FPGA) chip for accurate, ultrarapid next-generation sequencing (NGS) secondary data analysis with NextSeq 550Dx and a dedicated analysis module for Illumina DNA Prep with Enrichment Dx.
*Available only in select countries.
Key clinical research applications (in Research Mode)
The TruSight Tumor 170 workflow covers 170 genes associated with common solid tumors. It simultaneously analyzes DNA and RNA, covering a wide range of genes and variant types.
Prep
Comprehensive assay targeting DNA and RNA variants from the same FFPE tumor sample.
Assay targeting multiple variant types, including tumor mutational burden (TMB) and microsatellite instability (MSI), even from low-quality samples.
Sequence
NextSeq 500/550 v2.5 Reagent Kits
Ready-to-use reagent kits include the reagent cartridge, flow cell, and buffer. Multiple sequencing output and read length options available.
Analyze
TruSight Tumor 170 BaseSpace app
Analysis of reads from DNA and RNA libraries prepared using the TruSight Tumor 170 panel.
Intended Use for the NextSeq 550Dx Instrument
United States:
The NextSeq 550Dx Instrument is intended for targeted sequencing of DNA libraries from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue when used with in vitro (IVD) diagnostic assays. The NextSeq 550Dx Instrument is not intended for whole genome or de novo sequencing. The NextSeq 550Dx Instrument is to be used with specific registered, certified, or approved in vitro diagnostic reagents and analytical software.
European Union:
The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic assays. The NextSeq 550Dx instrument is to be used with specific registered, certified, or approved in vitro diagnostic reagents and analytical software.