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FDA Clears Rheumatoid Dx Test by Bio-Rad, Axis-Shield

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Bio-Rad Laboratories and Axis-Shield today announced the US Food and Drug Administration has cleared Bio-Rad's BioPlex 2200 Anti-CCP test for the early detection of rheumatoid arthritis.

The test, which is based on Axis-Shield's proprietary anti-CCP technology, is now being launched in the US. The test was made available outside the US earlier this year.

The test measures anti-cyclic citrullinated peptide antibodies, a biomarker that has demonstrated superior specificity in diagnosing rheumatoid arthritis. The assay runs on Bio-Rad's BioPlex 2200 system, a fully automated, random access multiplex testing system.

In 2007 Bio-Rad licensed Axis-Shield's test.

Ian Gilham, CEO of Axis-Shield, an in vitro diagnostic firm based in Scotland, said in a statement that the availability of the anti-CCP assay marks the first time that such a test will be offered on a multiplex autoimmune platform, "and we believe this will encourage market expansion as the autoimmune nature of many conditions become increasingly recognized."

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