NEW YORK (GenomeWeb News) – Illumina this week declared conformity with the requirements of the IVD Directive and has applied the CE mark for the MiSeqDx Cystic Fibrosis System. It added that it is finalizing plans to launch the product in "a number" of European countries that require CE marking. The system comprises Illumina's MiSeq benchtop next-generation sequencing instrument, two assays — the MiSeqDx Cystic Fibrosis Diagnostic Assay and the MiSeqDx Cystic Fibrosis Carrier Screening Assay — and associated software. The system is available for order in Europe beginning this month.

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