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Illumina, Inc. (ILMN) Applies CE Mark to MiSeqDx™ Cystic Fibrosis System



7/1/2013 8:49:02 AM

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SAN DIEGO--(BUSINESS WIRE)--Illumina, Inc. (NASDAQ:ILMN) today announced that it declared conformity with the requirements of the IVD Directive on June 26, 2013 and has applied the CE mark for the MiSeqDx Cystic Fibrosis System. The company is finalizing plans to commercialize the product in a number of European countries that require CE marking. The MiSeqDx Cystic Fibrosis System consists of the MiSeqDx next-generation sequencing instrument, two assays (the MiSeqDx Cystic Fibrosis Diagnostic Assay and the MiSeqDx Cystic Fibrosis Carrier Screening Assay), and associated software. Developed for the clinical molecular diagnostics market, the system leverages Illumina’s targeted resequencing chemistry to provide rapid and accurate identification of variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

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