SQI Diagnostics Announces Positive Results from SQiDworks(TM) Internal Performance Study



    - Automated laboratory system generates results equivalent to current
    biomarker testing technologies while providing substantial time and
    labour savings -

    TORONTO, Dec. 10 /CNW/ - SQI Diagnostics Inc. (TSX-Venture: SQD), a
medical systems automation company focused on evolving laboratory-based
biomarker testing, today announced positive results from an internal
performance study of SQiDworks(TM), its proprietary automated
multiple-biomarker test platform and QuantiSpot(TM), its corresponding
microarray consumable. The trial results demonstrated that SQI's automated
system generates equivalent results to current technologies, while providing
substantial time and labour savings.
    The trial evaluated the analytic performance of the SQiDworks/QuantiSpot
system, comparing its sensitivity and specificity to leading industry
technologies. The assay results correlated very well with current industry
standard devices (R2 of greater than 0.98) and showed wider dynamic ranges
compared to predicate ELISA tests. The internal validation study tested four
biomarkers commonly prescribed for diagnosing rheumatoid arthritis, focusing
on the CCP marker, which has been adopted rapidly over the last five years.
SQI Diagnostics designed a novel capture molecule highly specific for CCP
which showed a strong linear response and significantly improved sensitivity.
    "Our key assets are our ability to print microassay consumables at
unprecedented levels of quality, to design highly specific capture molecules,
and our extensive experience in laboratory automation. Leveraging these
skills, we have created a next generation platform capable of detecting and
quantifying multiple biomarkers rapidly and efficiently, which minimizes
manual labour requirements in laboratories," said Claude Ricks, CEO and
President of SQI Diagnostics. "We are now focused on commercializing this
platform while at the same time aggressively protecting the intellectual
property that surrounds it. The highly encouraging results from our internal
study allow us to focus on initiating our external validation trials in the
coming weeks and submitting an application for clearance to the FDA in the
first half of 2008."
    The Company has completed assembly of three SQiDwork platforms and
established a cGMP compliant facility to manufacture its QuantiSpot(TM)
microarray consumables. It has also trained the laboratory technicians from
the external validation sites in the operation of the platforms. SQI
Diagnostics intends to ship the automated platforms to the validation centres
by the end of 2007.

    Internal Validations Studies

    In a study conducted by SQI Diagnostics, human serum samples from 158
European and North American subjects, (118 rheumatoid arthritis sufferers and
40 control subjects) were tested using SQI Diagnostics' anti-CCP antibody
test. The study demonstrated that the test achieved 78% sensitivity and 97.5%
specificity. These results represent performance characteristics in line with
the best single analyte anti-CCP tests. A recently published study compared
nine industrial peers and 11 Anti-CCP antibody assays, including the first,
second, and third generation anti-CCP assays (Clin Chem. 2007 Aug;
53(8):1527-33. Analytical and diagnostic characteristics of 11 2nd- and
3rd-generation immunoenzymatic methods for the detection of antibodies to
citrullinated proteins. Bizzaro N, Tonutti E, Tozzoli R, Villalta D.). The
independent study tested 100 rheumatoid arthritis patients and 202 control
subjects and found that the sensitivities ranged from 41% to 74% at a fixed
specificity of 98.5%, for the 11 leading anti-CCP antibody ELISA tests.
    In a second study conducted by SQI Diagnostics, the sensitivity and the
specificity were compared with a leading competitor's CCP assay. At a fixed
specificity of 95%, the SQI Diagnostics anti-CCP assay was 4.2% more
sensitive. The SQI rheumatoid arthritis assay demonstrated 84.7% sensitivity
at a pre-set 95% specificity. The competitors assay demonstrated 80.5%
sensitivity at 95% specificity.
    "Currently, labs often mitigate unpredictable quality control by
repeating tests or by using multiple external controls," said Peter Lea, Chief
Scientific Officer of SQI Diagnostics. "The high level of performance and
quality control for our rheumatoid factor and anti-CCP antibody test is a
result of the development of our proprietary platform, a clear technical
understanding of CCP epitopes, surface attachment chemistry, and the
formulation of optimal capture reagents for capturing the anti-CCP antibodies
in rheumatoid arthritis patients. We expect that the technical enhancements
and automation of the SQiDworks/Quantispot system will provide laboratories
with systematic benefits in both quality and economic performance."

    About SQiDworks(TM)

    SQiDworks(TM) 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 QuantiSpot multiplexed tests can produce
quantified determinations for up to 960 individual test results per hour
resulting in significant laboratory efficiencies and cost-savings.

    About QuantiSpot(TM)

    The SQI Diagnostics microarray device, QuantiSpot(TM), is a multiplexed
assay consumable for use with the SQiDworks workstation. QuantiSpot tests are
currently being developed for the detection and quantification of biomarkers
used in the diagnosis of Autoimmune Disease, Infectious Disease and Allergic
conditions, among others. Each of the 96 wells of the QuantiSpot 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
quantify 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 automation company focused on
evolving laboratory-based biomarker testing. Using automation and proprietary
miniaturization technologies, SQI Diagnostics significantly improves the
economies of scale for laboratories performing multiple biomarker testing at
high volumes, allowing them to deliver patient results faster using less labor
and fewer resources. SQI Diagnostics' platform has a user-friendly interface,
100% quality control, high sample throughput and offers a more efficient
alternative to current testing options. SQI Diagnostics' initial products
target the $1.4 billion autoimmune disease market, with initial products for
Rheumatoid Arthritis and Thrombosis scheduled for launch in 2007. SQI
Diagnostics is based in Toronto, Canada. For further 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.

    %SEDAR: 00021000E




For further information:

For further information: Chief Financial Officer, Andrew Morris, (416)
674-9500 ext. 229, amorris@sqidiagnostics.com; Investor Relations, James
Smith, (416) 815-0700 ext. 229, jsmith@equicomgroup.com


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