TORONTO, Nov. 2 /CNW/ - SQI Diagnostics Inc. (TSX-V: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's automated SQiDworks(TM) Diagnostics Platform and its multiplexed IgXPLEX(TM) rheumatoid arthritis (RA) assay for marketing in the United States.
The SQiDworks Diagnostics Platform and its IgXPLEX RA assay provide clinical laboratories with the ability to simultaneously measure multiple biomarkers in a single test that delivers accurate patient results in less time, using less labour.
"Early and accurate diagnosis is crucial to the management and treatment of autoimmune conditions," said Professor Yehuda Shoenfeld M.D., FRCP, Head, Department of Medicine and Center for Autoimmune Diseases at Sheba Medical (Tel Aviv), "Now that SQI's multiplexing technology is cleared for sale in the United States, Canada and parts of the European Union, clinical labs in the western world have access to a cost-effective and highly efficient diagnosis platform to simultaneously analyze multiple biomarkers and deliver accurate patient results."
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 IgXPLEX technology to allow multiplexed measurement of target antibody sub-classes (IgA, IgG, IgM) for multiple biomarkers.
The lead test for the platform is the IgXPLEX RA assay, which provides simultaneous analysis of the biomarkers commonly tested and used to aid in the diagnosis and monitoring of rheumatoid arthritis, RF-IgA, RF-IgM and anti-CCP-IgG, a biomarker that has been rapidly adopted over the last five years.
"FDA clearance opens the door for SQI to the vast U.S. market and allows us to sell our technology's competitive advantages of speed, accuracy and efficiency to clinical laboratories focussed on keeping pace with the growing demand for biomarker testing," stated Claude Ricks, Chief Executive Officer of SQI. "We believe that combining our pipeline of multiplexed assays targeting autoimmune disease with our FDA-cleared system will be a tremendous competitive advantage in addressing our customers' needs. There are currently no other diagnostic platforms on the market that can offer labs the automation and multiplexing benefits that are intrinsic to our platform."
SQI's IgXPLEX product pipeline for 2010 includes the highest demand autoimmune test panels for Irritable Bowel Disease (Crohn's disease, ulcerative colitis), Celiac Disease, and Lupus.
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 multiplexed tests, can produce determinations for up to 960 individual test results per hour resulting in significant laboratory efficiencies and cost-savings.
The SQI Diagnostics microarray device, IgXPLEX, is a multiplexed assay consumable for use with the SQiDworks workstation. IgXPLEX tests are currently being developed for the detection and measurement of biomarkers used in the diagnosis of Autoimmune Disease, Infectious Disease and Allergic conditions, among others. Each of the 96 wells of the IgXPLEX 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 measure 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 labour, 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.
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SOURCE SQI Diagnostics Inc.
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