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 with in vitro (IVD) diagnostic assays. The NextSeq 550Dx Instrument is not intended for whole genome or de novo sequencing. The NextSeq 550Dx Instrument is to be used with specific registered, certified, or approved in vitro diagnostic reagents and analytical software.