Seek Flexibility for your Molecular Laboratory

Bring the benefits of next-generation sequencing (NGS) into the clinical lab with the first and only FDA-cleared NGS system for in vitro diagnostic use.

Illumina is the leading provider of accurate, reliable NGS solutions. Now clinical laboratories can take advantage of powerful NGS technology with the MiSeqDx system.

The MiSeqDx instrument is the first and only FDA-cleared in vitro diagnostic (IVD) next-generation sequencing system. Designed specifically for the clinical laboratory environment, the MiSeqDx instrument offers a small 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 kits and assays are available for use on the MiSeqDx system:

• MiSeqDx Universal Kit
o Develop your own diagnostic tests.

• MiSeqDx Cystic Fibrosis 139-Variant Assay
o The largest panel of clinically relevant and functionally validated variants for cystic fibrosis testing

• MiSeqDx Cystic Fibrosis Clinical Sequencing Assay
o An NGS test providing a comprehensive view of the CFTR gene.

The MiSeqDx instrument provides you maximum flexibility in your clinical lab.

Learn more by following the company website link below or click here for more information on the MiSeqDx platform.


Download the Cystic Fibrosis paper and learn more about the clinical significance of testing more variants when determining CF carrier status >> Download the paper

Download the New England Journal of Medicine Article ‘First FDA Authorization for Next-Generation Sequencer’ >> Download the paper

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

For In Vitro Diagnostic Use. Contact an Illumina representative for regional availability.