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FDA clears SQI's diagnostic platform and rheumatoid arthritis test

This article was originally published in Clinica

Executive Summary

Two new products from SQI Diagnostics have received 510(k) clearance from the US FDA: the automated SQiDworks diagnostic platform; and the multiplexed IgXPLEX rheumatoid arthritis (RA) assay. The test simultaneously measures multiple biomarkers involved in the disease, including rheumatoid factor (RF)-IgA, RF-IgM and anti-cyclic citrullinated peptide (CCP)-IgG. The new platform is a "significant advancement" from current standards of biomarker testing, which can be "inefficient and labour intensive", the Toronto, Canada-based company claims. SQI plans to release other IgXPLEX test panels in 2010, including those for irritable bowel disease, coeliac disease and lupus. The company CE marked the SQiDworks platform and its QuantiSpot RA assay for sale in Europe in February 2009.

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