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.
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.
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.
A user-friendly touch screen interface guides you as you create and set up your sample sheet, then load the sequencing cartridge (provided with pre-loaded reagents). During the run, the system allows you to monitor quality statistics. After DNA sequencing completes, the system software analyzes assay data and generates the results report.*
* Report generation is only available for the TruSight Cystic Fibrosis 139-Variant Assay, the TruSight Cystic Fibrosis Clinical Sequencing Assay, and the Extended RAS Panel.
*Report generation is only available for the TruSight Cystic Fibrosis 139-Variant Assay, the TruSight Cystic Fibrosis Clinical Sequencing Assay, and the Extended RAS Panel.
FDA-cleared, CE-IVD-marked next-generation sequencing test that conveniently provides two cystic fibrosis testing assays in one product.
The first FDA-approved NGS in vitro diagnostic for evaluating RAS mutations in colorectal cancer to determine patient eligibility for treatment with Vectibix®.
A validated, FDA-regulated and CE-IVD-marked kit enabling clinical laboratories to design their own next-generation sequencing assays for use on the MiSeqDx and NextSeq 550Dx systems.
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.