Illumina Inc.

- Model MiSeqDx - Next-Generation Sequencing (NGS) System


The MiSeqDx instrument is the first FDA-cleared in vitro diagnostic (IVD) next-generation sequencing (NGS) system. Designed specifically for the clinical laboratory environment, the MiSeqDx instrument is a desktop sequencer that incorporates an easy-to-follow workflow and an integrated software design to enable sample tracking, user traceability, and results interpretation.* Built on proven Illumina sequencing by synthesis (SBS) chemistry, the MiSeqDx instrument provides accurate, reliable screening and diagnostic testing, providing the speed and accuracy to enrich human understanding of disease, enabling earlier detection and reducing the time to diagnosis.

FDA-Cleared NGS System

The MiSeqDx instrument is the first to receive FDA clearance as a high-throughput DNA sequencing analyzer for next-generation sequencing-based assays. As an FDA-cleared IVD system, the MiSeqDx instrument meets guaranteed performance characteristics so you can feel confident that you are generating accurate and reliable data. With the MiSeqDx system, clinicians and clinical laboratories now have the tools to obtain comprehensive and reliable DNA sequencing results, enabling them to benefit from an expanding menu of IVD assays, while creating and deploying NGS-based molecular diagnostic tests for a wide-range of applications.

Compare MiSeq Systems

Find out how the MiSeq series enables a range of workflows with simplicity, speed, and exceptional accuracy for your clinical and research needs. By offering optimized library preparation kits, push-button sequencing, and automated data analysis, each MiSeq system delivers end-to-end sequencing solutions to meet the unique needs of both healthcare providers and scientific professionals.

A Growing IVD Menu

The MiSeqDx system currently runs two FDA-cleared cystic fibrosis assays, as well as an FDA-cleared MiSeqDx Universal Kit. In addition to these tests, Illumina is eager to expand the MiSeqDx menu through assays developed both in-house and with strategic partners. Whether you are looking for carefully designed NGS-based molecular diagnostic tests to uncover specific mutations or new targets for therapy, or you want to develop your own diagnostic tests, Illumina is committed to building the menu of resources you need.

  • MiSeqDx Cystic Fibrosis 139-Variant Assay
    • The largest panel (139) of clinically relevant, functionally validated variants for cystic fibrosis.
  • Cystic Fibrosis Sequencing assay
    • IVD NGS test providing a comprehensive view of the CFTR gene.
  • MiSeqDx Universal kit
    • Develop your own diagnostic tests.
  • Partner Assays
    • Illumina is working with a variety of outside partners to develop new clinical assays.

Simple NGS Workflow

The MiSeqDx instrument provides an easy-to-use, automated workflow. The compact, all-in-one instrument incorporates cluster generation, paired-end fluidics, sequencing by synthesis chemistry, and complete data analysis. An intuitive touch screen interface makes for simple instrument operation. Plug-and-play reagents with RFID tracking make for added security and convenience. The MiSeqDx instrument eliminates the need for auxiliary hardware and computing resources, saving valuable lab space.

Proven, Well-Published Technology

Illumina SBS chemistry is a widely adopted NGS technology worldwide, with references in more than 3,300 peer-reviewed publications. The MiSeqDx system uses the same proven reversible-terminator SBS chemistry used by all Illumina sequencing platforms.

User-Friendly, Intuitive Software

The MiSeqDx instrument is the first IVD NGS to offer a fully integrated sequencing ecosystem. Instrument software is accessed through a user-friendly touch screen interface. The Illumina Worklist Manager (IWM) software guides you through creation and setup of your sample sheet. MiSeq Operating Software (MOS) guides you through loading the sequencing cartridge (provided pre-loaded with reagents) and provides an overview of quality statistics for monitoring run progress. During the run, MOS also controls the flow cell stage, fluidics system, flow cell temperatures, and captures images of clusters on the flow cell. Upon completion of primary analysis, or base calling, the MiSeq Reporter (MSR) software analyzes assay data and generates the results report.

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