Rotkreuz, Switzerland, 8th  May  2008

Rheumatoid Arthritis: Fully-automated Anti-CCP assay launched by Roche Diagnostics

Roche Diagnostics announced today the launch of a fully-automated immunoassay for the determination of autoantibodies to cyclic citrullinated peptides (Anti-CCP).  The assay has been CE approved for use on the Elecsys / cobas e electrochemiluminescence immunoassay systems. The results of the Anti-CCP assay are intended to be used as an aid in the diagnosis of Rheumatoid Arthritis (in combination with other clinical and laboratory findings).

Rheumatoid arthritis is one of the most common autoimmune diseases, affecting 0.5-1% of the world population. This systemic disease is characterized by chronic inflammation of the synovial joints and progressive joint degeneration leading to loss of movement and to deformity over time. Early diagnosis of rheumatoid arthritis is important as early treatment may help to prevent joint damage and subsequent disability.

The diagnosis of rheumatoid arthritis relies on clinical symptoms and laboratory tests, such as rheumatoid factor and C-reactive protein. Anti-CCP is superior to both parameters in terms  of diagnostic specificity and predicts more severe disease course and outcome.

“We believe the Elecsys Anti-CCP  plays an important role in the early  diagnosis and treatment of rheumatoid arthritis and provides an excellent tool for primary care physicians and rheumatologists. The Elecsys Anti-CCP test marks another successful step in our strategy of offering the most comprehensive immunoassay test menu ”, said Dirk Ehlers, Head of Roche Professional Diagnostics.

About the test
The newly developed second-generation Elecsys Anti-CCP assay has been shown to meet the diagnostic requirements with excellent sensitivity and specificity in a short total test time of 18 minutes. The fully-automated assay complements Roche Diagnostics broad immunoassay menu on Elecsys and cobas e platforms which permit the use of both routine and special assays.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.com.

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