FDA Clears Siemens Anti-CCP Test for Rheumatoid Arthritis

Siemens Healthcare Diagnostics has obtained FDA clearance to offer U.S. laboratories an anti-cyclic citrullinated peptide (anti-CCP) IgG assay to aid diagnosis of rheumatoid arthritis (RA), a chronic, progressive autoimmune disease affecting approximately 1.3 million Americans.

Available on the company’s IMMULITE® 2000/2000 XPi immunoassay systems, the anti-CCP IgG assay affords laboratories the ability to integrate RA testing onto an automated, random-access analyzer.

RA causes joint inflammation and, without early diagnosis and aggressive treatment, may lead to joint destruction, organ damage and deformity. Currently, the anti-CCP antibody is considered the most specific RA marker and is critical for early diagnosis. High levels of the anti-CCP antibody also indicate more aggressive RA and higher joint damage risk compared to patients with lower levels.

With a clinical specificity of 97 percent, the IMMULITE anti-CCP IgG assay offers laboratories and clinicians a highly accurate diagnostic tool for fast and early RA diagnosis. The assay also helps rule out other inflammatory and arthritic conditions, enabling physicians to determine an appropriate treatment path.