Leverage the power of next-generation sequencing (NGS) in your clinical laboratory. The MiSeqDx System is the first FDA-regulated, CE-IVD-marked, NGS platform for in vitro diagnostic (IVD) testing.
FDA-Regulated and CE-IVD-Marked NGS System
The MiSeqDx instrument is the first Food and Drug Administration (FDA)-regulated and Conformite Europeene in vitro diagnostic (CE-IVD)-marked platform for NGS. The MiSeqDx instrument meets stringent performance characteristics so you can feel confident you are generating accurate and reliable data. With the MiSeqDx System, clinicians and clinical laboratories now have the tools to obtain comprehensive and reliable DNA sequencing results.
A Growing IVD Menu
Designed specifically for clinical laboratories, the MiSeqDx System delivers a broad range of sequencing applications right at your fingertips. Illumina offers two FDA-cleared cystic fibrosis assays and an FDA-approved companion diagnostic to aid in the identification of patients with colorectal cancer for treatment with Vectibix.*
*Vectibix is a registered trademark of Amgen, Inc.
Simple NGS Workflow
The MiSeqDx instrument provides an easy-to-use, automated workflow. An intuitive touch screen interface makes for simple instrument operation. Plug-and-play reagents with RFID tracking make for added security and convenience. The MiSeqDx instrument eliminates the need for auxiliary hardware and computing resources, saving valuable lab space.