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MiSeqDx

Molecular Diagnostics
Molecular Diagnostics

Harness the power of Illumina NGS to provide accurate, reliable data for screening and diagnostic testing, including assays for cystic fibrosis testing.
Expanding MiSeqDx Clinical Assay Menu
Expanding MiSeqDx Clinical Assay Menu

See how Illumina is collaborating with diagnostic technology partners to develop new clinical assays that can be used with the MiSeqDx System.
Compare MiSeqDx and MiSeq Systems
Compare MiSeqDx and MiSeq Systems

Each MiSeqDx system delivers comprehensive sequencing solutions to meet the unique needs of both healthcare providers and clinical researchers.

FDA-Regulated and CE-IVD-Marked NGS System

The MiSeqDx instrument is the the first Food and Drug Administration (FDA)-regulated and Conformite Europeene in vitro diagnostic (CE-IVD)-marked platform for NGS. The MiSeqDx instrument meets stringent performance characteristics so you can feel confident 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.

Next: A Growing IVD Menu

A Growing IVD Menu

Designed specifically for clinical laboratories, the MiSeqDx System delivers a broad range of sequencing applications right at your fingertips. Illumina offers two FDA-cleared cystic fibrosis assays and an FDA-approved companion diagnostic to aid in the identification of patients with colorectal cancer for treatment with Vectibix.*

*Vectibix is a registered trademark of Amgen, Inc.

Next: Simple NGS Workflow

Simple NGS Workflow

The MiSeqDx instrument provides an easy-to-use, automated workflow. 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.

Next: User-Friendly, Intuitive Software

User-Friendly, Intuitive Software

A user-friendly touch screen interface guides you as you create and set up your sample sheet, then load the sequencing cartridge (provided with pre-loaded reagents). During the run, the system allows you to monitor quality statistics. After DNA sequencing completes, the system software analyzes assay data and generates the results report.*

* Report generation is only available for the MiSeqDx Cystic Fibrosis 139-Variant Assay, the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and the Extended RAS Panel.

Start Over: FDA-Regulated and CE-IVD-marked NGS System
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Workflow

 
Prep

Choose from our menu of FDA-cleared assays available exclusively on the MiSeqDx System.

 
Sequence

The MiSeqDx instrument provides accurate, reliable data for screening and diagnostic testing.

 
Analyze

The selected analysis initiates automatically. It completes in a few hours and then generates a report.*

See MiSeqDx Application-Specific Workflows

*Report generation is only available for the MiSeqDx Cystic Fibrosis 139-Variant Assay, the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and the Extended RAS Panel.

System Specifications

540 Mb–15 Gb

output range

12-25 million

reads per run

2 × 300 bp

max read length

View All MiSeqDx Specifications

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関連ソリューション

Intended Use

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 for 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.