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.