Regulated reagents for IVD testing and assays for clinical research

Perform in vitro diagnostic testing and clinical research on the same instrument

NextSeq 550Dx Products & Services

Clinical diagnostic products

The Illumina DNA prep with Enrichment Dx and the NextSeq 550Dx High Output Reagent Kit are IVD reagents and consumables that work together to provide a flexible toolkit for developing and performing diagnostic tests on the NextSeq 550Dx.

VeriSeq NIPT Solution v2

VeriSeq NIPT Solution v2

For In Vitro Diagnostic Use. Contact an Illumina Representative for regional availability.

TruSight Tumor 170
TruSight Tumor 170

Comprehensive next-generation sequencing (NGS) assay that targets DNA and RNA variants from the same FFPE sample.

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TruSight Oncology 500
TruSight Oncology 500

Assay targeting multiple variant types, including microsatellite instability (MSI) and tumor mutational burden (TMB).

TruSight Hereditary Cancer Panel
TruSight Hereditary Cancer Panel

Expert-defined content targeting 113 genes associated with genetic cancer risk predisposition.

TruSight RNA Fusion Panel
TruSight RNA Fusion Panel

Provides comprehensive gene fusion detection in formalin-fixed, paraffin-embedded (FFPE) and other cancer research samples.

TruSight RNA Pan-Cancer
TruSight RNA Pan-Cancer

Targeting 1385 cancer genes for gene expression, variant, and fusion detection studies in many RNA sample types including blood, bone marrow, and formalin-fixed, paraffin-embedded (FFPE) tissue.

TruSight One Sequencing Panels
TruSight One Sequencing Panels

Comprehensive sequencing research panels targeting disease-associated regions of the exome with high analytical sensitivity and specificity.

Illumina DNA Prep with Exome 2.5 Enrichment
Illumina DNA Prep with Exome 2.5 Enrichment

A high-performance, fast, and complete whole-exome sequencing kit including library prep and hybridization reagents, a comprehensive exome probe panel, clean up/size selection beads, and indexes.

Respiratory Pathogen ID/AMR Enrichment Panel Kit
Respiratory Pathogen ID/AMR Enrichment Panel Kit

This NGS panel targets >280 respiratory pathogens (including SARS-CoV-2) and 2000+ antimicrobial resistance alleles, with data analysis powered by Explify RPIP.

Urinary Pathogen ID/AMR Enrichment Kit
Urinary Pathogen ID/AMR Enrichment Kit

The Urinary Pathogen ID/AMR Panel provides highly sensitive, culture-free identification and quantification of common and underrecognized uropathogens.

Viral Surveillance Panel
Viral Surveillance Panel

Viral Surveillance Panel offers whole-genome sequencing and characterization of 66 viruses including SARS-CoV-2, influenza, and polio with target enrichment.

Illumina Advantage Products

View a list of currently available off-the-shelf Illumina Advantage products tailored to the needs of clinical laboratories.

View Kits
Illumina Advantage Products
Local Run Manager (for diagnostic mode only)
Local Run Manager (for diagnostic mode only)

This software provides a user-friendly on-instrument solution for creating sequencing runs, monitoring run status, and analyzing data. It includes a Somatic Variant Module and Germline Variant Module.

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Software solutions (for Research Use Only)
BaseSpace Sequence Hub

Data management and simplified bioinformatics for labs getting started and for rapidly scaling next-generation sequencing (NGS) operations.

Correlation Engine

Correlation Engine is an interactive omics knowledgebase that puts private omics data in biological context with highly curated public data.

BaseSpace Variant Interpreter

BaseSpace Variant Interpreter allows scientists to rapidly identify biologically significant variants from human genomic data.

DRAGEN Enrichment

The DRAGEN Enrichment App aligns and optionally variant calls FASTQ, BAM or CRAM files, outputting a BAM, VCF, or both.

Illumina Connected Analytics

A secure genomic data platform to operationalize informatics and drive scientific insights.


 
 

Illumina services and support begins when the NextSeq 550Dx System is delivered. Illumina scientists and engineers assist with NGS system installation and setup and train laboratory personnel. In addition to on-site support, training courses are available to bring laboratory personnel quickly up to speed.

Illumina scientists are available 24/7 globally to answer questions every step of the way, enabling researchers to focus on making the next breakthrough discovery.


Illumina Product Care

In addition to the 1-year basic service warranty included with system purchase, Illumina offers maintenance, repair, and qualification solutions.

Illumina Training

Get high-quality results on Illumina technology even faster with instructor-led, hands-on courses and web-based training options.


* Contact your Illumina representative for more information about IVD development partnerships

Intended Use for the NextSeq 550Dx

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 for in vitro diagnostic (IVD) assays performed on the instrument. 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 and listed, cleared or approved, IVD reagents and analytical software.

European Union:
The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic (IVD) assays performed on the instrument. The NextSeq 550Dx instrument is to be used with specific registered, certified or approved in vitro diagnostic reagents and analytical software.