Illumina Applies CE Mark to Expanded MiSeqDx™ System

Illumina, Inc. has 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 single, easy-to-use system. The MiSeqDx Universal Kit includes the library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays on an in vitro diagnostic platform.

"The MiSeqDx demonstrates Illumina's continuing commitment to the clinical adoption of next-generation sequencing technologies. The company's validated products provide reliability and flexibility to our clinical customers," said Greg Heath, Senior Vice President and General Manager of Illumina's Diagnostics business. "The MiSeqDx greatly expands the opportunity for clinical laboratories to offer diagnostic tests for wide-ranging applications including genetic and infectious diseases and cancer."

The new functionality for the MiSeqDx, enabled by the MiSeqDx Universal Kit, will be commercialized in a number of European countries that require the CE mark, and will begin shipping in Europe beginning in November 2013.