NEW YORK (GenomeWeb News) – Canadian life science firm SQI Diagnostics today announced that the US Food and Drug Administration has cleared its SQIDworks platform and IgXPlex celiac qualitative assay.
The 4-plex microarray-based assay tests for anti-tissue transglutaminase IgG and IgA and is the second multiplexed assay cleared by the FDA to run on the SQIDworks platform, after clearance of SQI's IgXplex rheumatoid arthritis assay in late 2009.
The celiac assay previously received regulatory approval in Canada and CE marking in Europe.
Based in Toronto, SQI is developing a 6-plex quantitative celiac panel for the US market, which will include quantitative determinations of IgA and IgG anti-gliadin antibodies, IgA and IgG anti-tissue transglutaminase antibodies, and IgA and IgG anti-deamidated gliadin peptide antibodies, it said.