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SQI Diagnostics Submits FDA 510(k) and Health Canada Medical Device License Filings for its Multiplexed IgX PLEX(TM) Celiac Ass

^{Published on 2010-09-02 13:40:54 - Market Wire}
 

TORONTO, Sept. 2 /CNW/ - SQI Diagnostics Inc. (TSX-V: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that the United States Food and Drug Administration (FDA) has received the Company's 510(k) submission seeking marketing clearance in the U.S. for SQI's IgX PLEX Celiac Assay and automated SQiDworks(TM) Diagnostics Platform. In addition, SQI announced it has filed a Class II Medical Device License Application with Health Canada to permit the Company to market the IgX PLEX Celiac test and platform in Canada.

"Having already attained regulatory clearance for our IgX PLEX Rheumatoid Arthritis assay in combination with the SQiDworks platform, we are optimistic that we can achieve regulatory success with the Celiac assay and platform, and today's filings move us a step closer to that end," said Claude Ricks, Chief Executive Officer of SQI Diagnostics. "Our prospective clients are clinical laboratories that perform a diverse range of autoimmune biomarker testing. By supplying customers with more IgX PLEX autoimmune content to run on the SQiDworks platform, we can provide these labs with products to increase the profitability of their diagnostic testing because of our technology's labour reductions, multiplexing and efficiency."

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's IgX PLEX Celiac panel provides multiplex testing for four biomarkers associated with celiac disease including Anti-Tissue Transglutaminase: IgG & IgA and Anti-Gliadin IgG &IgA.

In addition to the IgX PLEX Celiac panel, SQI is moving forward with the product development process for IgX PLEX Vasculitis, IgX PLEX IA (infliximab), and IgX PLEX SLE (lupus) panels this calendar year. The Company anticipates that more IgX PLEX content will lead to an increase in customer evaluations, commercial adoption and revenue.

About SQI Diagnostics

SQI Diagnostics is a medical systems company that develops proprietary technology in multiplexing, miniaturization and automation. SQI provides laboratories the ability to simultaneously analyze multiple biomarkers, deliver accurate patient results in less time, significantly reduce labour, and increase profits...All in One Drop. For more information, please visit [ www.sqidiagnostics.com ]

Certain information in this press release is based on beliefs and assumptions of the Company's senior management and information currently available to it that may constitute forward-looking information within the meaning of securities laws. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties. Actual results, events, and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements.

This news release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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