NEW YORK (GenomeWeb) – Illumina said that Health Canada has granted a medical device license for the firm's MiSeqDx instrument along with its MiSeqDx Cystic Fibrosis 139-Variant Assay and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.
According to the firm, the approval is the first for a next-generation sequencing system in Canada.
Illumina received premarket clearance for the instrument and tests from the US Food and Drug Administration in November 2013. It also received FDA clearance of 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.
The MiSeqDx Cystic Fibrosis 139-Variant Assay simultaneously detects 139 clinically relevant disease-causing mutations and variants within the cystic fibrosis transmembrane conductance regulator gene. It covers all of the CF-causing variants recommended for carrier screening purposes by the American College of Medical Genetics and Genomics and referenced by the Canadian College of Medical Geneticists, as well as "many additional disease causing variants occurring in multiple ethnic sub-groups," said Illumina.