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FDA Clears SQI Multiplex Platform, Rheumatoid Arthritis Assay

NEW YORK (GenomeWeb News) – SQI Diagnostics today said that the US Food and Drug Administration has cleared for marketing its SQiDworks multiplex diagnostics platform and IgXPlex rheumatoid arthritis assay.

The SQiDworks automated platform uses the firm's IgXPlex technology to allow multiplexed measurement of target antibody sub-classes (IgA, IgG, IgM) for multiple biomarkers. The RA assay is 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, said Toronto-based 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," SQI CEO Claude Ricks said.

SQI's product pipeline for 2010 includes autoimmune test panels for irritable bowel disease, celiac disease, and lupus.

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