This instrument is the first FDA-regulated and CE-IVD-marked in vitro diagnostic (IVD) next-generation sequencing (NGS) system. Specifically designed for the clinical laboratory environment, the MiSeqDx instrument is a benchtop sequencer that utilizes an easy-to-follow workflow and an integrated software design that allows sample tracking, user traceability, and results interpretation.
The MiSeqDx instrument was built on Illumina sequencing by synthesis (SBS) chemistry, providing accurate, reliable screening and diagnostic testing, with the speed and accuracy to enrich human understanding of disease, enabling earlier detection and reducing the time to diagnosis. Illumina offers a growing menu of assays and kits enabling clinical laboratories to create and deploy NGS-based molecular diagnostic tests for cystic fibrosis, colorectal cancer, and a wide range of other applications.