FDA Clears Siemens Anti-CCP Test for Rheumatoid Arthritis

Jun 07, 2013

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 Americans1. 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.


Contact for journalists:

Susan Drew
Siemens Healthcare, Media Relations
Phone: +1 914-524-2844; E-mail: susan.drew@siemens.com

For further information on the IMMULITE anti-CCP assay, please visit: www.healthcare.siemens.com/autoimmune.

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Launched in November 2011, “Agenda 2013” is the initiative of the Siemens Healthcare Sector to further strengthen its innovative power and competitiveness. Specific measures, which will be implemented by the end of 2013, have been defined in four fields of action: innovation, competitiveness, regional footprint, and people development.


The Siemens Healthcare Sector is one of the world’s largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 48,000 employees worldwide and operates around the world. In fiscal year 2010 (to September 30), the Sector posted revenue of 12.4 billion euros and profit of around 750 million euros. For further information please visit: www.siemens.com/healthcare.

1Arthritis Foundation. Disease Center. Rheumatoid Arthritis. Available at: http://www.arthritis.org/conditions-treatments/disease-center/rheumatoid-arthritis/. Accessed 2/21/13.