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Illumina obtains FDA premarket clearance for MiSeqDx system

US-based Illumina has obtained premarket clearance from the US Food and Drug Administration (FDA) for the MiSeqDx system, a high-throughput DNA sequencing analyzer.

The company has also obtained premarket clearance from the FDA for the MiSeqDx cystic fibrosis 139-variant assay, MiSeqDx cystic fibrosis clinical sequencing assay, and MiSeqDx universal kit.

Taking advantage of Illumina’s sequencing by synthesis chemistry, the MiSeqDx instrument provides accurate, reliable screening, and diagnostic testing.

The MiSeqDx cystic fibrosis 139-variant assay has been designed for simultaneous detection of 139 clinically relevant disease-causing mutations and variants within the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Taking advantage of Illumina’s targeted resequencing chemistry, the MiSeqDx cystic fibrosis clinical sequencing assay provides highly accurate sequencing data for the protein coding regions and intron/exon boundaries of the CFTR gene.

The MiSeqDx Universal Kit comprises library preparation reagents, sample index primers, and sequencing consumables that are required for laboratories to develop amplicon assays on the in vitro diagnostic platform.

Illumina’s Diagnostics business general manager and senior vice president Greg Heath noted the company is proud to be the first company to obtain FDA clearance for a high-throughput DNA sequencing analyzer and next-generation sequencing-based assays.

"With the FDA clearance of the MiSeqDx, Illumina is providing clinicians and clinical laboratories with the tools needed to obtain comprehensive and reliable results from a DNA sequencing analyzer and enabling them to create and deploy NGS-based molecular diagnostic tests for cystic fibrosis and a wide-range of other applications," Heath added.

Illumina’s MiSeqDx system, MiSeqDx cystic fibrosis 139-variant assay, MiSeqDx cystic fibrosis clinical sequencing assay, and MiSeqDx universal kit are now available for immediate order with shipment before the end of 2013 in the US and Europe.