SQI Diagnostics Authorized to CE Mark its Automated SQiDworks(TM) Diagnostics Platform and QuantiSpot(TM) Rheumatoid Arthritis Assay



    TORONTO, Feb. 11 /CNW/ - SQI Diagnostics Inc. (TSX-Venture: SQD), a
medical systems automation company focused on evolving laboratory-based
biomarker testing, today announced that it is authorized to use the CE Mark on
the Company's automated SQiDworks(TM) Diagnostics Platform. The Company is
also authorized to use the CE Mark for its QuantiSpot(TM) Rheumatoid Arthritis
(RA) Assay, the first kit in a menu of microarray consumable tests being
developed for the SQiDworks platform. This regulatory milestone allows SQI to
market its automated platform and QuantiSpot RA test to diagnostic
laboratories in the European Union.
    "The ability to CE mark these products shows that we have met the
requisite health, safety and environmental protection requirements covering
these medical devices in the EU and is further validation that our technology
is ready for commercialization," said Claude Ricks, CEO and President of SQI
Diagnostics. "As in North America, European laboratories are seeking automated
solutions to respond to the growing demand for biomarker testing. While the
potential market for our platform in Europe is significant, our near-term
objective remains obtaining FDA clearance to market our platform and tests in
the U.S., and to initially focus our commercialization efforts in North
America."
    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 IgX-Plex(TM) technology to allow
multiplexed quantification of target antibody sub-classes (IgA, IgG, IgM) for
multiple biomarkers. The lead test for the platform is the QuantiSpot RA
assay, which provides simultaneous analysis of four biomarkers commonly tested
and used to aid in the diagnosis and monitoring of rheumatoid arthritis,
including the anti-CCP-IgG marker that has been adopted rapidly over the last
five years.

    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 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

    The SQI Diagnostics microarray device, QuantiSpot, 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 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 labor, 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.
    





For further information:

For further information: 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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