MiSeqDx Instrument products and services

Solutions for IVD workflow and clinical research

NGS-based IVD kits enabling clinical diagnostics, assay development, and clinical research across multiple applications

MiSeq Dx reagents

Featured IVD products (in Dx Mode)

TruSight Cystic Fibrosis

FDA-regulated, CE-marked in vitro diagnostic (IVD) next-generation sequencing assay conveniently providing two cystic fibrosis tests in one product.

MiSeqDx Reagent Kit v3

A validated, FDA-regulated, CE-marked IVD sequencing reagent kit, offering improved quality scores compared to previous versions.

Featured clinical research products (in RUO Mode)

Pillar® oncoReveal™ Myeloid Panel

A 78-gene pan-cancer panel with combined DNA/RNA content, utilizing the single-tube SLIMamp™ workflow for fast library prep and turnaround time.

Automation options

Software and informatics solutions

Instrument services and training

Intended use for the MiSeqDx Instrument

United States:

The MiSeqDx Instrument is intended for targeted sequencing of DNA libraries from human genomic DNA extracted from peripheral whole blood, formalin-fixed, paraffin-embedded (FFPE) tissue, or embryonic tissue, when used with 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.

European Union/other:

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 with 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.