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GEN News Highlights : Oct 20, 2009

FDA Clears Abbott’s Rheumatoid Arthritis Test

Assay detects levels of anti-CCP, an early marker of disease.

Abbott’s diagnostic test for rheumatoid arthritis has been approved by the FDA. The anti-CCP (antibody cyclic-citrulinated peptide) assay will be available on the company’s Architect immunoassay analyzers.

Many patients with RA develop an immune response against proteins containing citrulline before they present symptoms of the disease, Abbott explains. Studies have shown that detecting the level of these antibodies earlier in the disease continuum in conjunction with other clinical information is critical to the early diagnosis of the disease, the firm adds.

The assay was developed by Axis-Shield and will run on Abbott's Architect i1000SR and i2000SR systems. The anti-CCP assay is already approved and available on the Abbott Architect outside the U.S.