today announced that it has received notice that the United States Food and Drug Administration (FDA) has cleared the Company to market its proprietary Celiac Panel in the United States (US).
“We are very excited to have received FDA clearance,” said Andrew Morris, CEO, SQI Diagnostics. “This clearance lays the foundation for sales in the US market of our newest in vitro diagnostic (IVD) autoimmune test.” In addition to its suite of FDA cleared assays for celiac disease and rheumatoid arthritis, SQI is building a pipeline of other high-demand IVD autoimmune assays, including a quantitative 12-plex panel for lupus, a quantitative 3-plex panel for vasculitis, and an 8-plex panel for Crohn’s disease. “Our revenue growth during the last fiscal year was achieved through the development of custom multiplexed assays for pharmaceutical companies and their clinical research organizations and most recently, molecular testing in the animal and human health markets. This clearance demonstrates the Company’s ability to achieve success in the third multiplexing market in which it is involved: IVD autoimmune test development,” said Morris. “The clearance is also an important element in marketing our products and services with leading global pharmaceutical companies, and diagnostic partners in our newest area of molecular testing.”
Celiac disease is a medical condition in which the absorptive surface of the small intestine is damaged by gluten, resulting in an inability of the body to absorb nutrients necessary for good health. According to the New England Journal of Medicine1, it is estimated that 1 in 100 people in the United States is affected by celiac disease.
The SQI Celiac Panel is an Ig_plex Celiac DGP in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the use of a sqid-XTM system.
The American Journal of Gastroenterology has reported that as many as 97% of celiac sufferers were undiagnosed2. The 2013 American College of Gastroenterology guidelines and the American Gastroenterology Association recommend that tests for anti-tTG and anti-DPG should be part of routine testing for celiac disease3. Further, in a recent study by Health Quality Ontario, it was revealed that serologic testing for tTg has increased by 500% from 2004 to 20114.
For additional product information on the Ig_plex Celiac DGP Panel, please visit: http://sqidiagnostics.com/applications/ivd-and-clinical
1. Celiac Disease, Alessio Fasano, M.D., and Carlo Catassi, M.D., M.P.H., N Engl J Med 2012; 367:2419-2426, December 20, 2012.
2. Characteristics of adult celiac disease in the USA: results of a national survey. Green, P.H. et.al. American Journal of Gastroenterology, 2001, 2006.
3. Am J Gastroenterol, 2013; 108:656–676; doi: 10.1038/ajg.2013.79; published online 16 April 2013.
4. Health Quality Ontario Report, 2014.
Investor Relations Contact:
Chief Executive Officer
416.674.9500 ext. 229
Sales and Marketing Contact:
Vice President, Global Commercial Operations
About SQI Diagnostics
SQI Diagnostics is a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics. The Company’s proprietary microarray tests and fully-automated systems are designed to simplify protein and antibody testing workflow, increase throughput, reduce costs and provide excellent data quality. For more information, please visit www.sqidiagnostics.com.
This news release contains certain forward-looking statements, including, without limitation, statements containing the words “will”, “expects”, “intends” and other similar expressions which constitute “forward-looking information” within the meaning of applicable securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to risks related to the timing for the commencement of trading on the OTCQX, the increased awareness by the U.S. investor community of the Company, our continued listing on both the TSX Venture Exchange and the OTCQX, the failure to obtain necessary regulatory approvals, general economic and market segment conditions, and international risk and currency exchange, agreements and future agreements to sell our products, the acceleration of our revenue ramp, general economic and market segment conditions. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties and other risks detailed from time-to-time in the Company’s ongoing filings with the securities regulatory authorities, which filings can be found at www.sedar.com. Actual results, events, and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable laws.
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.