*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-regulated, CE-IVD-marked next-generation sequencing test that conveniently provides two cystic fibrosis testing assays in one product.
A validated, FDA-regulated, CE-marked IVD sequencing kit for use on the MiSeqDx instrument, offering improved quality scores compared to previous versions.
A validated, FDA-regulated 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.