Illumina Applies CE Mark to Expanded MiSeqDx™ System

Illumina, Inc.

today announced that it declared conformity with the requirements of the IVD Directive and has applied the CE mark to expand the use of the MiSeqDx system in clinical laboratories. These laboratories are now able to develop diagnostic tests using Illumina's new MiSeqDx Universal Kit on the MiSeqDx. The MiSeqDx Universal Kit joins the MiSeqDx Cystic Fibrosis Carrier Screening Assay and the MiSeqDx Cystic Fibrosis Diagnostic Assay in Illumina's expanding line of clinical products available for the MiSeqDx. The MiSeqDx uses Illumina's industry-leading sequencing by synthesis chemistry, the sequencing technology most widely adopted by genetics researchers worldwide. The instrument offers users the ability to run diagnostic or research applications on a