Health Canada grants SQI license to market IgX PLEX Celiac Panel

Apr 29 2011

SQI Diagnostics Inc. (TSXV: SQD), a medical systems automation company focused on evolving laboratory-based autoimmune biomarker testing, today announced it has received a license from Health Canada permitting the Company to market its IgX PLEX™ Celiac Panel, a quantitative 4-plex panel, which will run on SQI's automated SQiDworks™ Diagnostics Platform.

This marks the Company's fourth multiplexed panel, and its second quantitative panel, approved by Health Canada.

"This Health Canada license for our second-generation celiac assay provides prospective customers with another autoimmune test to run on our automated platform, which can increase the profitability of their diagnostic testing owing to our technology's benefits of labour reductions, multiplexing and efficiency," said SQI Diagnostics CEO Claude Ricks. "While we are excited about the Canadian marketplace, we are also working diligently towards the commercialization of our second-generation quantitative products for the U.S. market."

SQI's second-generation multiplexed celiac panel measures and reports four analytes simultaneously: Anti-gliadin (AGA) IgA, AGA IgG, Anti-tissue transglutaminase (tTG) IgA and Anti-tTG IgG.

In 2010, Health Canada granted SQI a license to sell its first-generation, 4-plex qualitative IgX PLEX celiac panel. The Company believes that second-generation, quantitative assays have the potential to be perceived more favourably by the marketplace because they provide clinicians with additional tools to quantify the levels of biomarkers associated with diseases. Quantification is important to understand disease levels and progression.

The Company anticipates that its quantitative celiac product line will progress further later this year with the release of a 6-plex quantitative panel that adds the emerging biomarkers deaminated Gliadin (DGP) IgA and IgG to the current 4-plex panel.

Outside of North America, SQI expects to launch sales efforts in Europe in the second half of 2011 for its quantitative rheumatoid arthritis and celiac multiplexed assays and SQiDworks platform.

Celiac disease is a common autoimmune disorder brought on by the consumption of the protein gluten, which is found in foods containing wheat, barley or rye. Celiac disease causes an immune reaction in the small intestine, causing damage to the surface of the small intestine and an inability to absorb certain nutrients. A recent study in the peer reviewed journal Gastroenterology reported that the incidence of celiac disease has quadrupled since 1950 to one in 106 Americans, and that the disease remains poorly diagnosed.

In addition to its suite of celiac assays, SQI is building greater pipeline depth by developing a number of other high-demand autoimmune assays including a quantitative 6-plex celiac panel, a quantitative 12-plex panel for lupus and a quantitative 3-plex panel for vasculitis. These assays remain on track to be filed with various regulatory bodies including Health Canada and the FDA this year.