Empowering clinical sequencing around the globe
Leverage the power of NGS to develop, validate, and conduct a range of IVD assays and clinical research on one compact sequencing instrument
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IVD-compliant in over 45 countries, the MiSeqDx Instrument is built to withstand the rigor and precision of the IVD world through proven Illumina sequencing by synthesis (SBS) chemistry, 21 CFR part 11 compliant software, and accurate data analysis to support physicians and clinical laboratories worldwide.
The MiSeqDx Instrument enables clinical laboratories to apply the power of genomics to cystic fibrosis testing, reproductive health, oncology testing, and more.
The MiSeqDx Instrument provides integrated workflow, fast turnaround time, and plug-and-play reagents for simple operation.
With two operating modes, the MiSeqDx Instrument offers the flexibility to run diagnostic assays, conduct clinical research, and develop your own laboratory developed test (LDT) all on one instrument.
System specificationsa
a. Results based on MiSeqDx Reagent Kit v3.
From library prep to informatics, the MiSeqDx Instrument provides easy-to-follow workflows and integrated software that deliver accurate, reliable screening and diagnostic testing.
Manage your workflow seamlessly with Clarity LIMS or your existing LIMS system.
Choose from a menu of FDA-cleared assays available exclusively on the MiSeqDx Instrument.
Produce sequences with ready-to-use reagents featuring proven Illumina sequencing by synthesis chemistry.
Analyze data automatically at the completion of a run with Local Run Manager.
Generate detailed reports using TruSight Software Suite.a
a. Report generation is only available for the TruSight Cystic Fibrosis 139-Variant Assay, the TruSight Cystic Fibrosis Clinical Sequencing Assay, and through third-party IVD assay modules.
With the flexibility to operate in either Research Use Only (RUO) or Dx Mode, the MiSeqDx Instrument can conduct clinical research, develop, and run a range of IVD assays on the same instrument.
Detect causative and clinically relevant variants for cystic fibrosis with FDA-cleared next-generation sequencing panels.
Develop IVD assays on the MiSeqDx Instrument, the first FDA-regulated and CE-IVD-marked next-generation sequencing system for in vitro diagnostic use.
MiSeqDx Instrumenta |
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| Run time | 24 hr | < 35 hr | ≤ 45 hr |
| Maximum output per run | ≥ 5 Gb | ≥ 90 Gb | ≥ 3 Tb |
| Maximum paired-end reads per run | ≥ 15M | > 300M | ≥ 20B |
| Read length | 2 × 150 bpd | 2 × 150 bp | 2 × 150 bp |
| Data quality | ≥ 80% of bases higher than Q30 | > 75% of bases higher than Q30 | ≥ 85% of bases higher than Q30 |
| Data analysis offeringse | Dx Mode: Local Run Manager RUO Mode: Local Run Manager, Illumina Connected Analytics, on-premises DRAGEN server |
Dx Mode: Local Run Manager, dedicated DRAGEN server RUO Mode: Local Run Manager, Illumina Connected Analytics, on-premises DRAGEN server |
Dx Mode: Dedicated DRAGEN server RUO Mode: Dedicated DRAGEN server, BaseSpace Sequence Hub, Illumina Connected Analytics |
a. Libraries generated with TruSeq Custom Amplicon Kit Dx.
b. Libraries generated with Illumina DNA Prep with Enrichment Dx.
c. Based on a single S4 flow cell.
d. Maximum read length on MiSeqDx Instrument is 2 × 300 bp in RUO mode.
e. A dedicated DRAGEN server is paired with an Illumina sequencing system and can be used to plan secondary analysis as part of sequencing run using the Illumina Run Manager. An on-premises DRAGEN server does not communicate directly with the sequencing system but can ingest and process data from any Illumina sequencing system via a command-line.
FDA-regulated, CE-marked in vitro diagnostic (IVD) next-generation sequencing assay conveniently providing two cystic fibrosis tests in one product.
A validated, FDA-regulated, CE-marked IVD sequencing reagent kit, offering improved quality scores compared to previous versions.
A library preparation and enrichment solution for in vitro diagnostic (IVD) targeted sequencing applications.
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.
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.
Interested in an application or assay and want to know if the MiSeqDx Instrument is right for your lab? Contact us today for more information.
Your email address is never shared with third parties.
