FDA Clears SQI's Automated SQiDworks Diagnostics Platform and IgXPLEX Rheumatoid Arthritis Assay for Sale in the United States

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Mon Nov 2, 2009 8:03am EST

FDA Clears SQI's Automated SQiDworks Diagnostics Platform and IgXPLEX
Rheumatoid Arthritis Assay for Sale in the United States

TORONTO, Nov. 2 /PRNewswire-FirstCall/ - SQI Diagnostics Inc. (TSX-V: SQD), a
medical systems automation company focused on evolving laboratory-based
biomarker testing, today announced that the U.S. Food and Drug Administration
(FDA) has cleared the Company's automated SQiDworks(TM) Diagnostics Platform
and its multiplexed IgXPLEX(TM) rheumatoid arthritis (RA) assay for marketing
in the United States.
The SQiDworks Diagnostics Platform and its IgXPLEX RA assay provide clinical
laboratories with the ability to simultaneously measure multiple biomarkers in
a single test that delivers accurate patient results in less time, using less
labour.
"Early and accurate diagnosis is crucial to the management and treatment of
autoimmune conditions," said Professor Yehuda Shoenfeld M.D., FRCP, Head,
Department of Medicine and Center for Autoimmune Diseases at Sheba Medical
(Tel Aviv), "Now that SQI's multiplexing technology is cleared for sale in the
United States, Canada and parts of the European Union, clinical labs in the
western world have access to a cost-effective and highly efficient diagnosis
platform to simultaneously analyze multiple biomarkers and deliver accurate
patient results."
The SQiDworks automated platform is a significant advancement from the current
industry standard methods for biomarker testing, which can be inefficient and
labour intensive. The platform is used to analyze multiple biomarkers in a
fully automated 'load-and-go' process. The platform incorporates the Company's
proprietary IgXPLEX technology to allow multiplexed measurement of target
antibody sub-classes (IgA, IgG, IgM) for multiple biomarkers.
The lead test for the platform is the IgXPLEX RA assay, which provides
simultaneous analysis of the biomarkers commonly tested and used to aid in the
diagnosis and monitoring of rheumatoid arthritis, RF-IgA, RF-IgM and
anti-CCP-IgG, a biomarker that has been rapidly adopted over the last five
years.
"FDA clearance opens the door for SQI to the vast U.S. market and allows us to
sell our technology's competitive advantages of speed, accuracy and efficiency
to clinical laboratories focussed on keeping pace with the growing demand for
biomarker testing," stated Claude Ricks, Chief Executive Officer of SQI. "We
believe that combining our pipeline of multiplexed assays targeting autoimmune
disease with our FDA-cleared system will be a tremendous competitive advantage
in addressing our customers' needs. There are currently no other diagnostic
platforms on the market that can offer labs the automation and multiplexing
benefits that are intrinsic to our platform."
SQI's IgXPLEX product pipeline for 2010 includes the highest demand autoimmune
test panels for Irritable Bowel Disease (Crohn's disease, ulcerative colitis),
Celiac Disease, and Lupus.

About SQiDworks

The SQiDworks Diagnostics Platform is a fully-automated fluidics workstation,
scanner and analytical device used to process SQI Diagnostics proprietary
QuantiSpot microarray test devices. The platform fully integrates all assay
steps for hands-free work-flow and is compatible with standard lab automation
systems. The platform is capable of processing up to 240 patient samples per
run, and, when combined with the Company's multiplexed tests, can produce
determinations for up to 960 individual test results per hour resulting in
significant laboratory efficiencies and cost-savings.

About IgXPLEX

The SQI Diagnostics microarray device, IgXPLEX, is a multiplexed assay
consumable for use with the SQiDworks workstation. IgXPLEX tests are currently
being developed for the detection and measurement of biomarkers used in the
diagnosis of Autoimmune Disease, Infectious Disease and Allergic conditions,
among others. Each of the 96 wells of the IgXPLEX device contains proprietary
microarrays for duplicate antibody capture, in-sample calibration and
redundant test controls. When combined with the SQiDworks fully-automated
workstation, users are able to process multiplexed assays to measure serum
concentrations of up to 12 individual biomarkers or the qualitative detection
of up to 24 biomarkers per patient.

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 and quantitative 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 release was prepared by management of the Company who takes full
    responsibility for its contents. The TSX Venture Exchange has not
    reviewed and does not accept responsibility for the adequacy or accuracy
    of this news release.


SOURCE  SQI Diagnostics Inc.

Chief Financial Officer, Andrew Morris, (416) 674-9500 ext. 229,
amorris@sqidiagnostics.com; Media and Investor Relations, Adam Peeler, (416)
815-0700 ext. 225, apeeler@equicomgroup.com
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