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FDA Clears SQI’s Automated SQiDworks Diagnostics Platform, IgXPLEX Rheumatoid Arthritis Assay For Sale In The US

SQI Diagnostics Inc. (SQI ), a medical systems automation company focused on evolving laboratory-based biomarker testing, said that the US Food and Drug Administration (FDA) has cleared for marketing its automated SQiDworks Diagnostics Platform and its multiplexed IgXPLEX rheumatoid arthritis assay for marketing in the US.

The company claims that 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.