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The MiSeqDx instrument is the first and only FDA-cleared in vitro diagnostic (IVD) next-generation sequencing (NGS) system. Designed specifically for the clinical laboratory environment, the MiSeqDx instrument offers a small, approximately 4 square feet (0.3 square meters) footprint, an easy-to-follow workflow, and data output tailored to the needs of clinical labs. In addition, the integrated software enables sample tracking, user traceability, and results interpretation*. Taking advantage of proven Illumina sequencing by synthesis (SBS) chemistry, the MiSeqDx instrument provides accurate, reliable screening, and diagnostic testing.
Currently, three ready-to-use FDA-cleared tests are available:
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.
Each optimized MiSeqDx assay kit enables sample multiplexing, maximizing operator efficiency and increasing throughput. Input DNA is prepared for sequencing on the MiSeqDx instrument following a streamlined process that includes ready-to-use reagents, creating a highly efficient workflow with minimal hands-on time.
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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.
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The MiSeqDx instrument is equipped with Illumina User Management Software that enables laboratories to control and trace system access, ensuring that only authorized personnel are running tests.
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.
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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.
* Detailed results reports are available for the MiSeqDx Cystic Fibrosis 139-Variant Assay and the
MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.