SQI enters clinical validation agreement with University North Carolina Kidney Center for Vasculitis Assay

Apr 15 2011

Third Party Validation of SQI's Vasculitis Assay a Prerequisite for FDA Submission

SQI Diagnostics Inc. (TSX-V: SQD), a medical systems automation company focused on evolving laboratory-based autoimmune biomarker testing, today announced it entered into a clinical validation agreement with University North Carolina Kidney Center, Chapel Hill, to evaluate SQI's new multiplexed, automated approach for biomarker detection in vasculitis.

Vasculitis is an autoimmune disease that causes inflammation of the blood vessels, and can present as renal vasculitis, which is a form of kidney disease. SQI's automated platform (SQiDworks™) will be used to analyze multiple biomarkers associated with vasculitis in a fully automated 'load-and-go' process. The platform incorporates the Company's proprietary IgXPLEX™ technology to allow multiplexed analysis and measurement of target antibodies and antibody sub-classes.

Dr. Ronald J. Falk, Director of University North Carolina Kidney Center, will be the principal investigator of the validation study. Dr. Falk has characterized several of the diagnostic and prognostic markers for vasculitis found in blood serum, and has been intricately involved in establishing internationally recognized clinical classification systems for vasculitis.

When the validation study is complete, SQI will compile and analyze the data and intends to submit the results to the U.S. Food and Drug Administration seeking its clearance to market the Vasculitis IgXPLEX assay.

"Third party validation of our Vasculitis IgXPLEX assay is a necessary step towards FDA clearance of the assay, so it's imperative that we work with a partner of University North Carolina Kidney Center's caliber who we believe can provide crucial insight and knowledge to move the development of our vasculitis assay forward," said Claude Ricks, President and CEO of SQI Diagnostics. "In addition, we look forward to future collaborations with the world's center of excellence for the diagnoses of vasculitis, which we believe will heighten the autoimmune diagnostic community's awareness of our pioneering technology, and provides us with direct access to a number of North America's top physicians who specialize in the diagnoses of this disease."

"We are looking forward to the opportunity to work with SQI's multiplexed technology because we see it as a tool that has the potential to more effectively and efficiently support the diagnoses of autoimmune diseases such as vasculitis," said Dr. Falk, who is also Chief, Division of Nephrology and Hypertension, University of North Carolina. "As modern medicine continues its rapid evolution, working with companies such as SQI supports our commitment to leverage new and innovative laboratory testing solutions in order to enhance our leadership position in the field."

As part of the agreement, SQI is working to establish a center of excellence for microarray-based multiplex testing of vasculitis with Dr. Falk through the delivery of a SQiDworks platform at Chapel Hill.  The agreement calls for co-publishing of the results of the collaborative efforts. SQI anticipates that this platform can be used for expanded purposes alongside the collaboration with Dr. Falk including, but not limited to, validation of additional products in the Company's pipeline.