Health Canada issues license for IgX PLEX Celiac test kit

Sep 21 2010

SQI Diagnostics Inc. (TSX-V: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that Health Canada has issued a medical device license for its automated IgX PLEX Celiac(TM) microarray test kit that runs on the Company's automated SQiDworks(TM) platform. The license allows the Company to market and sell the IgX PLEX Celiac product in Canada.

"The addition of the IgX PLEX Celiac test kit to our growing portfolio of commercially available assays provides our current and prospective customers with another assay to run on the SQiDworks platform, joining our previously approved test kit for Rheumatoid arthritis," said Claude Ricks, President and CEO of SQI Diagnostics. "As more assays become commercially available, the potential return on investment for labs that are considering purchasing the Company's technology increases, which may ultimately accelerate SQI's revenue ramp."

SQI believes its automated technology significantly improves upon the current industry standard methods for biomarker testing, which can be inefficient and labour intensive.

The SQiDworks automated platform is used to analyze multiple-biomarkers in a fully automated 'load-and-go' process. The platform incorporates the Company's proprietary IgX-Plex(TM) technology to allow multiplexed analysis and measurement of target antibodies and antibody sub-classes.

The Celiac IgX PLEX test kit provides multiplex testing used to aid in the diagnosis of celiac disease through the measurement of four biomarkers including Anti-Tissue Transglutaminase: IgG & IgA and Anti-Gliadin: IgG &IgA.

Celiac disease is a digestive condition 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.

SQI announced in early September that the United States Food and Drug Administration (FDA) received the Company's 510(k) submission seeking marketing clearance in the U.S. for its PLEX Celiac Assay and automated SQiDworks diagnostics platform. The regulatory approval process with the FDA remains on track.

In addition to the IgX PLEX Celiac panel, SQI is moving forward with the product development process for IgX PLEX Vasculitis, IgX PLEX IA (anti-TNF), and IgX PLEX SLE (lupus) panels. The Company anticipates that more IgX PLEX content will lead to an increase in customer evaluations of its SQiDworks platform, commercial adoption and revenue.