The MiSeqDx System is the first NGS platform to receive FDA clearance for in vitro diagnostic (IVD) testing. 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 MiSeqDxSystem delivers a broad range of sequencing applications right at your fingertips. Two FDA-cleared cystic fibrosis assays are available, as well as an FDA-cleared universal kit that lets you create and deploy your own NGS-based molecular diagnostic tests.
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 pre-loaded with 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 MiSeqDx Cystic Fibrosis 139-Variant Assay and the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.
*Report generation is only available for the MiSeqDx Cystic Fibrosis 139-Variant Assay and the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.
FDA-cleared NGS assay with the largest panel of clinically relevant, functionally validated cystic fibrosis variants in a diverse population.
FDA-cleared next-generation sequencing assay provides a full view of coding regions of the CFTR gene, to aid in in vitro diagnosis of cystic fibrosis.
A validated, FDA-cleared kit that enables molecular diagnostic laboratories to design their own next-generation sequencing assays for use on the MiSeqDx System.