Work within a regulated sequencing workflow for developing diagnotic tests and leveraging future NGS IVD tests in the pipeline, while retaining the flexibility to work in a research environment and use the full range of Illumina sequencing methods for a wide range of applications.
The instrument and sequencing reagents are all regulated by the FDA, developed under design control principles, manufactured under Current Good Manufacturing Practices (cGMPs), and verified for consistent assay performance.
Paired with the TruSeq Custom Amplicon Kit Dx library preparation kit and the NextSeq 550Dx Reagent Kit, the NextSeq 550Dx is part of an IVD development toolkit that enables clinical labs to design clinical assays with regulated components*.
*Contact your Illumina representative for more information about IVD development partnerships.
The NextSeq 550Dx 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 NextSeq 550Dx instrument is not intended for whole genome or de novo sequencing. The NextSeq 550Dx instrument is to be used with registered and listed, cleared or approved, IVD reagents and analytical software.
The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic (IVD) assays performed on the instrument. The NextSeq 550Dx instrument is to be used with specific registered, certified or approved IVD reagents and analytical software.