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News

FDA Clearance for cystic fibrosis assays

Illumina : 21 November, 2013  (New Product)
The MiSeqDx DNA sequencing analyzer from Illumina receives pre-market clearance from the US FDA
FDA Clearance for cystic fibrosis assays


Illumina has received premarket clearance from the US Food and Drug Administration (FDA) for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance. Illumina also received FDA premarket clearance for the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit.



The MiSeqDx benchtop sequencer offers users the ability to run diagnostic or research applications on a single, easy-to-use system. Designed and validated for the clinical market, the MiSeqDx with the portfolio of FDA-cleared in vitro diagnostic kits and assays leverage Illumina’s sequencing by synthesis (SBS) chemistry for high confidence in results.



The MiSeqDx Cystic Fibrosis 139-Variant Assay is designed for simultaneous detection of 139 clinically relevant disease-causing mutations and variants within the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The assay includes all cystic fibrosis-causing variants recommended for carrier screening purposes by the American College of Medical Genetics and Genomics (ACMG) and the American College of Obstetricians and Gynaecologists (ACOG).



The MiSeqDx Cystic Fibrosis Clinical Sequencing Assay makes use of Illumina’s targeted resequencing chemistry to provide highly accurate sequencing data for the protein coding regions and intron/exon boundaries of the CFTR gene.



The MiSeqDx Universal Kit enables clinical laboratories to develop their own diagnostic tests. The kit includes library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays on the in vitro diagnostic platform.



“Illumina is proud to be the first company to obtain FDA clearance for a high-throughput DNA sequencing analyzer and next-generation sequencing-based assays,” said Greg Heath, Senior Vice President and General Manager of Illumina’s Diagnostics business. “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.”



 


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