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FDA clears Axis-Shield's rheumatoid arthritis test

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for Axis-Shield's anti-CCP test for rheumatoid arthritis (RA). The diagnostic, which runs on Abbott's Architect family of analysers, detects antibodies to cyclic citrullinated peptide (CCP), which can appear in patients' blood before symptoms start. Dundee, UK-based Axis-Shield claims that its test is more specific than rheumatoid factor, a traditional diagnostic for RA. Anti-CCP testing is gaining acceptance, with the European League Against Rheumatism adding it to its diagnostic criteria for early-stage RA. Axis-Shield has an estimated a 40% share of this market, with about five million tests carried out per year. Abbott launched the test outside the US in January 2009, and will introduce it in the US later this month.

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