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Abbott Launches AXIS-SHIELD Anti-CCP Rheumatoid Arthritis Test on the Architect Analyser

The following press release was published by Axis-Shield.

Dundee, Scotland, 6 January, 2009: Axis-Shield plc (LSE:ASD, OSE:ASD), the international in-vitro diagnostics (IVD) company, today announces that it has completed the development and manufacturing of a new assay for anti-CCP, used in the early diagnosis of rheumatoid arthritis (RA), to run on Abbott’s Architect® family of automated immunoassay analysers.

Rheumatoid Arthritis (RA) is a chronic autoimmune disease characterised by inflammation of the lining of the joints, causing pain and disability. The disease occurs in about 1 in a 100 people in all races and ethnic groups and, although it often begins in middle age and is particularly prevalent in older people, it can also develop in children and young adults. RA occurs in 2-3 times more women than men.

“The introduction of tests recognising anti-citrullinated protein antibodies has caused a revolution in rheumatology. The antibodies may occur in the blood long before the onset of symptoms and the anti-CCP test is superior to rheumatoid factor (RF) regarding diagnostic specificity for RA, and is often associated with potentially more severe disease course and outcome”, reports Dr. Thomas Skogh at the Linkoping University Hospital in Sweden.

Many pharmaceutical companies with rheumatology interests are now recognising the possible treatment benefits of early disease diagnosis using anti-CCP testing, and the European Union League against Rheumatism (EULAR) has added the test to its diagnostic criteria for early RA. Recent US studies have also advocated the inclusion of anti-CCP testing into the American College of Rheumatology (ACR) guidelines for diagnosing RA.

Abbott, an industry leader in the provision of comprehensive test menus on proprietary automated systems to clinical laboratories, is adding the anti-CCP test to its Architect platforms, which are designed to address the changing needs of laboratories of all sizes. The automated systems provide workflow efficiencies and allow laboratories to integrate immunoassay and clinical chemistry testing on one platform.

The new assay has been launched in non-US markets only and an application has been filed with the FDA for U.S. marketing clearance. Ian Gilham, Axis-Shield CEO, commented: “We are pleased to have launched another proprietary assay on Abbott’s flagship Architect system. We believe this will help to address the growing demand for the anti-CCP test and larger volume batch testing. Rheumatoid arthritis is a potentially debilitating disease and earlier disease diagnosis facilitates improved treatment options and offers substantial patient benefits.”


For more information on Axis-Shield www.axis-shield.com.


2009