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Abbott gets rheumatoid arthritis test clearance

This article was originally published in The Gray Sheet

Executive Summary

Abbott plans to launch an Architect immunoassay in the U.S. by year-end to aid in the diagnosis of rheumatoid arthritis after receiving 510(k) clearance Oct. 20. The antibody cyclic-citrulinated peptide test is designed to run on Abbott's Architect i1000SR and i2000SR systems and is already available outside the U.S., according to the company. "Many patients with RA develop an immune response against proteins containing citrulline long before they present symptoms of the disease," the firm notes. "Studies show 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.
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