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;

1.MiSeqDx Universal Kit

Develop your own diagnostic tests

2.MiSeqDx Cystic Fibrosis 139-Variant Assay

The largest panel (139) of clinically relevant, functionally validated variants for cystic fibrosis.

3.MiSeqDx Cystic Fibrosis 139-Variant Assay

IVD NGS test providing a comprehensive view of the CFTR gene

Innovative technologies

At Illumina, our goal is to apply innovative sequencing and array technologies to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service.
As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative sequencing and array-based solutions for genomic analysis serve as tools for disease research, drug discovery, and the development of molecular tests in clinical labs.

Leading-edge products and services

Illumina has developed a comprehensive line of products that address the scale of experimentation and the breadth of functional analysis required to achieve the goals of molecular medicine. Our offering includes leading-edge solutions for:
SNP genotyping
Copy number variation
Genome sequencing
DNA methylation studies
Transcriptome analysis
Gene expression profiling
Our products and services are used by a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the globe.