TORONTO, Nov. 7, 2014 /PRNewswire/ - SQI Diagnostics
Inc. (the "Company" or "SQI Diagnostics") (TSX-V: SQD) (OTCQX:
SQIDF) 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
- 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.
- Characteristics of adult celiac disease in the USA: results of a national survey. Green, P.H.
et.al. American Journal of Gastroenterology, 2001, 2006.
- Am J Gastroenterol, 2013; 108:656–676; doi:
10.1038/ajg.2013.79; published online 16
April 2013.
- Health Quality Ontario Report, 2014.
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.
Forward-looking Information
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.
SOURCE SQI Diagnostics Inc.