FDA-cleared and FDA-approved assays for in vitro diagnostics

Clinical testing applications intended for use on the MiSeqDx instrument

MiSeqDx Applications & Methods

Illumina products for cystic fibrosis testing are FDA-cleared and validated to meet stringent performance criteria for molecular diagnostics. Our next-generation sequencing (NGS) assays provide visibility into the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Ultimately, this information can be used to make informed family planning decisions and choose optimized treatments, potentially leading to a better quality of life.

Clinical laboratories can develop their own next-generation sequencing (NGS) assays for the MiSeqDx instrument using the TruSeq Custom Amplicon Kit Dx. This amplicon sequencing solution lets molecular diagnostics labs develop assays using oligonucleotide probes they have designed on their own.

This provides users with the flexibility to target specific regions of interest and better meet the needs of their customers. 

In partnership with pharmaceutical companies and the oncology community, we are developing companion diagnostic tests that detect biomarkers linked to disease to allow for appropriate treatment decisions.

The Extended RAS Panel is the first FDA-approved NGS-based companion diagnostic for RAS mutational testing in colorectal cancer to determine eligibility for Vectibix® treatment.* We intend to expand the menu of clinical assays offered on the MiSeqDx System, ultimately leading to more effective targeted therapies.

*Vectibix is a registered trademark of Amgen, Inc.

Illumina MiSeqDx Research Applications

Research Applications on MiSeqDx System

In Research mode on the MiSeqDx System, you can access any application or method that can be done on the MiSeq System. Perform targeted gene, small genome, and amplicon sequencing, as well as 16S metagenomics and targeted gene expression analysis.

See All MiSeq Research Applications

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.