TORONTO, Nov. 25 /CNW/ - SQI Diagnostics Inc. (TSX-Venture: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that Health Canada has issued medical device licenses for the Company’s automated SQiDworks(TM) platform, and its first microarray consumable test developed for the platform, the QuantiSpot RA(TM) microarray.
“The Health Canada licenses are important milestones in the commercialization strategy for our SQiDworks platform and our menu of QuantiSpot tests,” said Claude Ricks, CEO and President of SQI Diagnostics. “These licenses allow us to begin selling our technology immediately to customers in Canada ahead of our U.S. launch, which will provide us with valuable feedback from labs seeking to maximize efficiency while ensuring accuracy with their diagnostic testing.”
SQI believes its automated technology significantly improves upon the current industry standard methods for biomarker testing, which can be inefficient and labour intensive.
The SQiDworks automated 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). 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.
In September, SQI 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) Diagnostics Platform and QuantiSpotTM RA Assay consumable test performed consistently at all sites, at a level that is equivalent to the performance of FDA-cleared manual diagnostic devices. SQI’s platform however delivers significantly greater efficiencies in costs and labour.
About SQiDworks
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.
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 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 and 2009. 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
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
Source: SQI Diagnostics Inc.
