Bringing next-generation sequencing to clinical labs

Regulated sequencing platforms with stringent performance characteristics for diagnostic use

In Vitro Diagnostic (IVD) Instruments

Explore in vitro diagnostic (IVD) instruments designed for the clinical lab environment. With easy-to-follow workflows and integrated software, our IVD instruments deliver accurate, reliable screening and diagnostic testing. Clinical labs can develop and perform their own next-generation sequencing (NGS) tests, run predefined gene panels, or pursue a variety of clinical research applications.

IVD Instruments Tailored for Clinical Labs
  MiSeqDx Instrument NextSeq 550Dx Instrument NovaSeq 6000Dx Instrument
Key Applications – Diagnostic Mode Cystic Fibrosis Testing
IVD Assay Development
Target Enrichment
Cancer Companion Diagnostics
Future Illumina Assays
Future Partner Assays
IVD Assay Development
Future Illumina Assays
Future Partner Assays
Target Enrichment
Noninvasive Prenatal Testing (NIPT)
Comprehensive Genomic Profiling (TruSight Oncology Comprehensive EU)
Targeted Enrichment (Illumina DNA Prep with Enrichment Dx)
Future Illumina Assays
Future Partner Assays
IVD Assay Development
Key Applications – Research Mode Targeted Gene Sequencing (amplicon, gene panel)
Metagenomic Analysis
Small Whole-Genome Sequencing

See More Research Applications
Exome Sequencing
Targeted Gene Sequencing (amplicon, gene panel)
Whole-Transcriptome Sequencing
Cytogenomic Arrays

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Whole-Genome Sequencing
Targeted DNA Sequencing (high-throughput exome and large custom enrichment panels)
Whole-Transcriptome Sequencing
Targeted RNA Sequencing (exome, custom enrichment panels)
Methylation Sequencing
System Software Fully integrated ecosystem including on-instrument data analysis. Software partitioned for IVD and RUO applications. Diagnostic mode features Local Run Manager software, enabling users to record samples, specify sequencing run parameters, and select analysis modules. Fully integrated ecosystem including on-instrument data analysis. Software partitioned for IVD and RUO applications. Diagnostic mode features Local Run Manager software, enabling users to record samples, specify sequencing run parameters, and select analysis modules. Fully integrated ecosystem including paired, on-premise DRAGEN server and license for accelerated secondary analysis. IVD and Research modes enable IVD testing and clinical research applications with no system reboot needed. Illumina Run Manager is integrated on system for simplified run management. Use Illumina BaseSpace Sequence Hub for accurate, rapid secondary analysis.
Output Range ≥ 5 Gb ≥ 90 Gb S2: ≥ 1 Tb S4: ≥ 3 Tb
Run Time 24 hours < 35 hours S2: ≤ 40 hours S4: ≤ 45 hours
Reads per Run ≥ 15 million > 300 million Up to 20 B reads in IVD Mode or Research Mode
Maximum Read Length in Diagnostic Mode 2 × 150 bp 2 × 150 bp 2 × 150 bp
Samples per Run Depending on assay Depending on assay 8-192 samples/run depending on assay
Regulatory Status For In Vitro Diagnostic Use.
Contact us for regional availability.
Class II Exempt (US), CE-IVD
For In Vitro Diagnostic Use.
Contact us for regional availability.
Class II Exempt (US), CE-IVD
For In Vitro Diagnostic Use.
Contact us for regional availability.
Class II Exempt (US), CE-IVD
Compatible Products See All See All See All
Reproductive Health
Reproductive Health

From preconception to noninvasive prenatal testing, our technologies deliver fast, accurate information that can guide prenatal and reproductive care.

Learn more about
reproductive health
Oncology
Oncology

Next-generation sequencing has the potential to transform how cancer will be diagnosed and treated in the future.

Learn more about NGS in oncology
Genetic Health
Genetic Health

Our technologies can help genetic disease researchers identify causative genetic variants and chromosomal aberrations.

Learn more about genetic health
Molecular Diagnostics
Molecular Diagnostics

Next-generation sequencing offers the speed and accuracy to enrich human understanding of disease, enabling earlier detection and reducing the time to diagnosis.

Learn more about molecular diagnostics