SQI Diagnostics Announces Positive Results from Mt. Sinai/Cleveland Clinic External Multi-Site Validation Studies



    
    - SQiDworks(TM) automated platform for multiple-biomarker testing
    generates accurate and consistent results across all sites -
    

    TORONTO, Sept. 17 /CNW/ - SQI Diagnostics Inc. (TSX-Venture: SQD), a
medical systems automation company focused on evolving laboratory-based
biomarker testing, today announced positive results from its external
validation tests conducted at The Cleveland Clinic in Cleveland, Ohio, and
Mount Sinai Hospital in Toronto, Canada. The results demonstrated that SQI's
automated SQiDworks(TM) platform and QuantiSpot RA(TM) microarray consumable
test performed consistently at all sites, at a level that is equivalent to the
performance of U.S. Food and Drug Administration-approved manual diagnostic
devices, while offering significantly greater efficiencies in costs and
labour.
    "As part of working with SQI, we conducted internal verification
comparing our current IVD technology and SQI's QuantiSpot RA assay," said
Dr. Sihe Wang, Section Head Clinical Biochemistry, at the Cleveland Clinic.
"Our method comparison results are equivalent to results that SQI reports and
our participation in the Multi-Site Reproducibility studies confirmed these
results. The data tells us that the SQiDworks platform is equivalent in
clinical performance to existing technologies yet provides automation and
multiplexing benefits that are not available to reference labs today."
    "We've seen significant growth in the demand for biomarker testing across
a range of diseases, and these types of tests often require a high degree of
manual effort to perform," said Dr. Ken Pritzker, CEO of Mount Sinai Services.
"There hasn't been a multiplexing technology available that conducts testing
for multiple biomarkers (IgG, IgA and IgM) of the same antigen which is the
core of autoimmune disease testing. An automated platform that enables
multiplexing like SQI's would require far less time of our technical staff,
and would greatly enhance our ability to meet growing demands for timely
patient results from these complex tests."
    The SQiDworks automated platform is used to analyze multiple-biomarkers
in a fully automated 'load-and-go' process. The lead test for the platform is
the QuantiSpot RA assay, which provides simultaneous analysis of four
biomarkers commonly prescribed 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.
    "Today's announcement is pivotal for SQI, as this is the final major
piece of performance data on our platform that is required for our
applications to the FDA and other regulators for clearance to market our
technology," stated Claude Ricks, Chief Executive Officer of SQI. "The
increasing use of multiple biomarkers to routinely diagnose and monitor many
disease conditions has dramatically increased workloads on hospital and
commercial laboratories. Our fully automated microarray platform will be a key
solution to addressing this demand."

    Study Results:

    The data announced today were derived from blinded validation studies
which consisted of three main components: clinical sensitivity and
specificity, method correlation, and multi-site reproducibility.

    Clinical Sensitivity and Specificity

    Validation studies completed at SQI Diagnostics demonstrated that its
multiplexed QuantiSpot RA assay run on the automated SQiDworks platform has
industry-leading performance for clinical sensitivity and specificity. The
sensitivity and specificity were determined by comparing the QuantiSpot RA
test results to known patient samples. Patient samples were analyzed for the
presence of the following four biomarkers typically used to assist in the
diagnosis of rheumatoid arthritis:

    
    ------------------------------------------------------
      Clinical Sensitivity and Specificity  n equals 520
    ------------------------------------------------------
                   RF-IgA    RF-IgG    RF-IgM    CCP-IgG
    ------------------------------------------------------
    Sensitivity      75%       72%       89%       77%
    ------------------------------------------------------
    Specificity      92%       71%       93%       95%
    ------------------------------------------------------

    Method Correlation
    

    Validation studies at SQI compared the QuantiSpot RA tests run on the
SQiDworks platform to manual FDA-approved predicate diagnostic methods. The
results of this method correlation study, using 350 samples, demonstrated a
positive correlation in diagnostic outcome to predicate devices currently
available on the market.

    
    ------------------------------------------------------
                       Method Correlation  n equals 350
    ------------------------------------------------------
                      Positive     Negative      Overall
    ------------------------------------------------------
    RF-IgA               93%          80%          87%
    ------------------------------------------------------
    RF-IgG               74%          57%          65%
    ------------------------------------------------------
    RF-IgM               88%          87%          88%
    ------------------------------------------------------
    Anti-CCP-IgG         92%          90%          91%
    ------------------------------------------------------

    Multi-Site Reproducibility

    The blinded multi-site study conducted at Cleveland Clinic, Mount Sinai
Services and SQI demonstrated the reproducibility of the QuantiSpot RA test on
the SQiDworks platform when performed using different operators, lots and at
different sites. The table below shows that the assays run on the platforms at
each of the sites consistently and accurately determined the same diagnostic
outcome.

    ------------------------------------------------------
                            Multi-Site Reproducibility
    ------------------------------------------------------
                            IgA     IgG     IgM     CCP
    ------------------------------------------------------
    Lot-to-Lot             100%     93%    100%     98%
    ------------------------------------------------------
    Operator-to-Operator    99%     97%    100%     98%
    ------------------------------------------------------
    Site-to-Site            98%     96%    100%     98%
    ------------------------------------------------------

    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
labour and fewer resources. SQI Diagnostics' platform has a user-friendly
interface, 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 2008. 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.





For further information:

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


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