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Illumina Receives FDA Clearance for MiSeqDx, Cystic Fibrosis Assays

NEW YORK (GenomeWeb News) – Illumina said today that it has received premarket clearance from the US Food and Drug Administration for its MiSeqDx system, two cystic fibrosis assays, and a library prep kit that enables laboratories to develop their own diagnostic tests.

The designation marks the first time a next-generation sequencing system has received FDA premarket clearance.

"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," Greg Heath, senior vice president and general manager of Illumina's diagnostics business, said in a statement.

The two cystic fibrosis assays include the MiSeqDx Cystic Fibrosis 139-Variant Assay, which detects 139 clinically relevant mutations and variants within the cystic fibrosis transmembrane conductance regulator (CFTR) gene. It includes all the variants recommended for carrier screening by the American College of Medical Genetics and Genomics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG).

The MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, meantime, sequences the protein coding regions and intron/exon boundaries of the entire CFTR gene.

Illumina also received premarket clearance for its MiSeqDx Universal Kit, which includes library preparation reagents, sample index primers, and sequencing consumables that laboratories can use to develop their own assays on the cleared MiSeqDx system.

In a statement, Francis Collins, director of the National Institutes of Health, called the decision a "landmark move that will help realize the promise of personalized medicine."

He added that he "commends" the FDA for both the immediate impact of the decision, as well as "the pathway it has created for the clearance of future devices that may incorporate further improvements in sequencing technology and cost effectiveness."

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