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FDA clears Axis-Shield/Bio-Rad's anti-CCP rheumatoid arthritis test

This article was originally published in Clinica

Executive Summary

Axis-Shield and Bio-Rad Laboratories have launched an anti-cyclic citrullinated peptide (CCP) test for rheumatoid arthritis in the US, after receiving 510(k) clearance from the FDA. The test is based on Axis-Shield's technology and runs on Hercules, California-based Bio-Rad's BioPlex 2200 system. The companies launched it outside the US and Japan early this year (www.clinica.co.uk, 5 January 2010). CCP antibodies can appear in patients' blood before the onset of symptoms, and testing was added to guidelines from the American College of Rheumatology and the European League Against Rheumatism in August, which could boost uptake of the diagnostic. Dundee, UK-based Axis-Shield also produces an FDA-cleared anti-CCP test that run on Abbott's Architect analysers. However, this is the first time that anti-CCP testing has been available on a multiplex autoimmune platform.

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