MiSeqDx Instrument applications and methods

Expand your possibilities

Powerful benchtop sequencing system for development of in vitro diagnostic assays and clinical research

MiSeq Dx flow cell

Key diagnostic applications

Illumina FDA-cleared and validated next-generation sequencing (NGS) assays for cystic fibrosis testing empower clinicians to screen for known cystic fibrosis transmembrane conductance regulator (CFTR) gene variants before interrogating the gene for novel mutations.

Read application note 

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Library prep
2
Sequence
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Analyze

Local Run Manager

On-instrument software for creating sequencing runs, monitoring run status, and analyzing data. 

Cystic fibrosis assays can be run using the associated Local Run Manager software analysis modules.

Illumina DNA Prep with Enrichment Dx allows clinical laboratories to develop their own NGS assays targeting specific regions of interest using custom oligonucleotide probes. 

1
Library prep
2
Sequence
3
Analyze

Local Run Manager

On-instrument software for creating sequencing runs, monitoring run status, and analyzing data. 

Illumina DNA Prep with Enrichment Dx can be run using the associated Local Run Manager software analysis modules.

Key clinical research applications (in research mode)

Illumina sequencing facilitates clinical cancer research by providing expert-defined gene content, accurate data, and simple analysis and reporting options. Select from a variety of Illumina and third-party kits that help easily and quickly identify variants in virtually any type of cancer, including solid tumors and hematological malignancies. 

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Library prep
2
Sequence
3
Analyze

NGS provides powerful and comprehensive solutions for infectious disease detection and characterization. Using Illumina kits and assays, clinical labs can take a deeper look into viruses, bacteria, fungi, and parasites that affect human health.  

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Library prep
2
Sequence
3
Analyze

Intended use for the MiSeqDx Instrument

United States:

The MiSeqDx Instrument is intended for targeted sequencing of DNA libraries from human genomic DNA extracted from peripheral whole blood, formalin-fixed, paraffin-embedded (FFPE) tissue, or embryonic tissue, when used with in vitro diagnostic (IVD) assays performed on the instrument. The MiSeqDx Instrument is not intended for whole genome or de novo sequencing. The MiSeqDx Instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.

European Union/other:

The MiSeqDx 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 diagnostic (IVD) assays performed on the instrument. The MiSeqDx Instrument is not intended for whole genome or de novo sequencing. The MiSeqDx Instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.