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An IVD-regulated mid-throughput sequencing platform for clinical laboratories. Dual research and diagnostic modes support the flexibility to perform IVD testing, LDT development, and clinical research on a single instrument.
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In this video, an Illumina Field Applications Scientist discusses what to expect during the preinstallation, shipping, and delivery stages. We’ll highlight important steps in the process and introduce you to available resources.
Library preparation is a required sequencing step. Use our selection tool to determine the best library prep kit for your needs based on your application, method, species and more.
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NextSeq™ 550Dx Sequencing System
20005715
The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic 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.The instrument includes a dual boot configuration to enable the use of the instrument in either diagnostic (Dx) or research use only (RUO) mode. In vitro diagnostic sequencing assays, including the Germline and Somatic Variant Modules, are executed in diagnostic mode. Only IVD sequencing reagents can be utilized in diagnostic mode.
NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD
20028870
Includes one high output flow cell, one buffer cartridge, and one reagent cartridge containing clustering and sequencing reagents to support a 75-cycle run on the NextSeq 550Dx System. All products registered for In Vitro Diagnostic sequencing.
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NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD
20028871
Includes one high output flow cell, one buffer cartridge, and one reagent cartridge containing clustering and sequencing reagents to support a 300-cycle run on the NextSeq 550Dx System. All products registered for In Vitro Diagnostic sequencing.
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NextSeq 550Dx High Output Reagent Kit v2.5 (75 or 300 cycles)
Library prep kit for IVD assay development or RUO use
IVD assay development: Illumina DNA Prep with Enrichment Dx
RUO applications: library prep kit for your chosen application and method
Optional products:
Air filter replacement (recommended every 90 days)
In Dx Mode, the NextSeq 550Dx Instrument supports targeted sequencing using Illumina DNA Prep with Enrichment Dx. Additionally, Veriseq NIPT Solution v2, TruSight Oncology Comprehensive (EU), and other commercially available third-party IVD assays are also available on the NextSeq 550Dx Instrument.
The NextSeq 550Dx Instrument offers a Diagnostic Mode (Dx Mode) and a Research Mode (RUO Mode). These dual modes provide the flexibility to perform IVD testing, LDT development, and clinical testing on a single instrument. Runs performed in Dx Mode are processes regulated by US and EU regulatory bodies. Learn more about developing IVD assays or contact an Illumina representative for more information about IVD development partnerships.
To design custom assays on the NextSeq 550Dx Instrument, use the Illumina DNA Prep with Enrichment Dx kit, a library prep and enrichment solution for IVD targeted sequencing applications. This kit enables clinical labs to add targeted sequencing to their menu of diagnostic applications and offers a core component of the IVD assay pathway for performing validated NGS tests.
The NextSeq 550Dx Instrument in RUO Mode supports all currently available clinical applications, including exome sequencing, transcriptome profiling, user-designed targeted panels, and microarray scanning. To learn more, visit the NextSeq 550 System applications and methods page.
See the similarities and differences between all Illumina IVD instruments here. Contact an Illumina representative with questions about choosing the right instrument for you.
Advanced chemistry, optics, and informatics combine to deliver exceptional speed and data quality, outstanding throughput and scalability.
Optimized reagent kit that provides increased cluster density and read length, improving sequencing quality scores compared to earlier versions.
Enable CGP with a large pan-cancer panel covering all major variant classes plus gene signatures (TMB, MSI, and HRD) from FFPE tissue.
A fast, integrated workflow for preparing libraries for use in a wide range of sequencing applications.
These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.
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.
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.
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