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SQI Diagnostics Receives Health Canada Medical Device License for its Celiac Test Kit
- Ig_plex® Celiac DGP Panel simultaneously quantifies peptide and antibody biomarkers associated with celiac disease -
Toronto, Ontario
February 24, 2014
SQI Diagnostics Inc. (TSX-V: SQD),

a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, today announced it has received a license from Health Canada permitting the Company to market its multiplexed Ig_plex® Celiac DGP Panel.

“This panel will provide clinicians with a valuable and rapid tool to quantify the levels of multiple key biomarkers associated with celiac disease,” said Andrew Morris, CEO of SQI Diagnostics. “Furthermore, this panel quantifies both peptide biomarkers and antibody biomarkers simultaneously, highlighting the ability of SQI’s platform to detect, measure and subtype a range a protein types within a single multiplexed test, enabling a whole new class of diagnostic combinations to be possible.”

The Ig_plex Celiac DGP Panel is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease. The multiplexed assay provides semi-quantitative determination of the IgG and IgA immunoglobulin classes of DGP (deaminated gliadin peptide) and tTG (anti-tissue transglutaminase) antibodies in a single test requiring only one human sample. The panel operates on the sqid-X™ system, an automated diagnostic analyzer that can process hundreds of patient samples per hour. The Company is filing for regulatory approvals for the Ig_plex Celiac DGP Panel in additional jurisdictions.

The overall agreement between commercially available predicate methods for detecting the four analytes compared with the Ig_plex Celiac DGP Panel from SQI which detected the four distinct analytes simultaneously, was very high. The overall agreement for the specific analytes is as follows:

Analyte Overall Agreement (%) (n=264)
tTG IgA 98.5 %
tTG IgG 89.0 %
DGP IgA 96.2 %
DGP IgG 96.2 %

Celiac disease is a common autoimmune disorder triggered 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 105 Americans, and that the disease remains poorly diagnosed.

In addition to its suite of assays for celiac disease and rheumatoid arthritis, SQI is building a pipeline of other high-demand 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. The Company has also developed a suite of custom protein microarray assays to measure immunogenicity for pharmaceutical companies and their clinical research organizations.

For additional product information on the Ig_plex Celiac DGP Panel, please go to http://sqidiagnostics.com/applications/ivd-and-clinical.

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.

Investor Relations Contact:

Chief Executive Officer
Andrew Morris
416.674.9500 ext. 229
amorris@sqidiagnostics.com

VP Corporate Development
James Smith
416.674.9500 ext. 241
jsmith@sqidiagnostics.com

Forward-Looking Information

This press release contains certain forward-looking statements, including, without limitation, statements containing the words “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “believe”, “in the process”, “is subject to” 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, our need for additional capital to sustain our business, statements with respect to sales of our Ig_plex® Celiac DGP product and analytical systems, agreements and future agreements to sell our products, the success of our Diagnostic Tools and Services business and our intent to build near-term revenue streams from this business, the completion of our second-generation sqidlite platform, the build-out of our portfolio of quantitative tests, the successful regulatory filing and receipt of regulatory approvals for our later stage quantitative diagnostic kits , the acceleration of our revenue ramp, general economic and market segment conditions, competitor activity, technology changes and regulatory approvals. 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 securities laws.

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