Third Party Validation of SQI's Vasculitis Assay a Prerequisite for FDA
TORONTO, April 14 /CNW/ - 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
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
"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
"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
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
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SOURCE SQI Diagnostics Inc.
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