Both systems deliver the consistency and reliability of a clinical instrument. Learn how these solutions differ to find the right system for your clinical lab.
 NextSeq 550Dx |
 MiSeqDx |
|
|---|---|---|
| Regulatory Status | Class II Exempt CE-IVD |
Class II Exempt CE-IVD |
| IVD Assay Menu | Future Illumina Assays Future Partner Assays |
TruSight Cystic Fibrosis Extended RAS Panel Future Illumina Assays Future Partner Assays |
| Diagnostic Assay Design Kits | TruSeq Custom Amplicon Dx TruSeq Custom Amplicon Dx - FFPE QC Dx |
TruSeq Custom Amplicon Dx TruSeq Custom Amplicon Dx - FFPE QC Dx |
| Sequencing Consumables | NextSeq v2 Reagent Kits NextSeq v2 IA Reagent Kits NextSeq 550Dx Reagents |
MiSeq Reagent Kit v3 |
| Applications in Research Mode | Same as NextSeq550 or MiSeq From small gene panels to exomes |
Same as MiSeq From small to medium-sized gene panels |
| System Software | Fully integrated ecosystem including on-instrument data analysis. Software partitioned for IVD and RUO applications. Diagnostic mode features Local Run Manager software, enabling users to record samples, specify sequencing run parameters, and select analysis modules. | Fully integrated ecosystem including on-instrument data analysis. Software partitioned for IVD and RUO applications. Diagnostic mode features Local Run Manager software, enabling users to record samples, specify sequencing run parameters, and select analysis modules. |
*Contact your Illumina representative for more information about IVD development partnerships.
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 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 IVD reagents and analytical software.
