TORONTO, Oct. 29 /CNW/ - SQI Diagnostics Inc. (TSX-Venture: SQD), a
medical systems automation company focused on evolving laboratory-based
biomarker testing, announced today that the United States Food and Drug
Administration (FDA) has received the Company's 510(k) submission. The 510(k)
is seeking marketing clearance in the United States from the FDA for SQI's
automated SQiDworksTM platform and QuantiSpot RATM microarray consumable test.
In addition, SQI has filed a Class II Medical Device License Application
with Health Canada. Once approved, the Class II Medical Device License will
permit the Company to market its automated SQiDworks platform and QuantiSpot
RA microarray consumable test in Canada.
"This is a significant milestone for SQI as it moves us one step closer
to the commercial launch of our first products," said Claude Ricks, Chief
Executive Officer of SQI. "During the past three weeks, we announced positive
external validation test results for our automated platform, and appointed a
seasoned expert in the sales and marketing of biomarker test platforms to
spearhead our commercial launch. Today's regulatory actions are the final
tasks we needed to complete to position SQI for revenue generation."
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.
SQI expects that its automated technology will significantly improve upon
the current industry standard methods for biomarker testing, which can be
labour intensive and inefficient.
SQiDworks 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.
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 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
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
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
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