TORONTO, Sept. 17 /PRNewswire-FirstCall/ - 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:
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.
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.
CONTACT: 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