NEW YORK (GenomeWeb News) – Toronto-based SQI Diagnostics said today that its second-generation test for celiac disease has been approved by Health Canada for marketing.
The approval of the IgXPlex Celiac Panel, a quantitative 4-plex test that runs on SQI's automated SQiDworks diagnostics platform, follows Canadian approval of SQI's IgX Plex Celiac microarray test kit in September.
According to the company, the new test may be more attractive to customers "because they provide clinicians with additional tools to quantify the levels of biomarkers associated with diseases."
The second-generation test measures and reports four analytes simultaneously — anti-gliadin IgA; anti-gliadin IgG; anti-tissue transglutaminase; and anti-tissue transglutaminase IgG.
The test is the fourth multiplexed panel and second quantitative panel from SQI to be approved by Canadian regulators, the company said.
In a statement, CEO Claude Ricks said the firm is "working diligently" to bring its second-generation quantitative products to the US market. It also plans to launch sales efforts in Europe in the second-half of this year for its quantitative rheumatoid arthritis and celiac multiplexed assays and SQiDworks platform.