Regulatory Approval Process with the FDA Remains on Track
TORONTO, Sept. 21 /CNW/ - 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.
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.
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SOURCE SQI Diagnostics Inc.
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