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AXIS-SHIELD RECEIVES FDA CLEARANCE FOR THE ANTI-CCP RHEUMATOID ARTHRITIS TEST ON ABBOTT'S ARCHITECT® ANALYSER
Dundee, Scotland, 16 October, 2009: Axis-Shield plc (LSE:ASD, OSE:ASD), the international in vitro diagnostics (IVD) company, today announces that it has received marketing clearance from the US Food and Drug Administration (FDA) for an assay for anti-CCP, used in the 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. It affects approximately one in every 100 people of all races and ethnic groups. The introduction of tests recognising antibodies to cyclic citrullinated peptides has caused a revolution in rheumatology. The antibodies may occur in the blood long before the onset of symptoms and it is believed 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.
The European Union League against Rheumatism (EULAR) has added the anti-CCP test to its diagnostic criteria for early-stage 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 launched the Architect® anti-CCP assay in non-US markets earlier this year and it will introduce the test in the USA later this month.
Ian Gilham, Axis-Shield CEO, commented: "We are pleased to have received FDA clearance for this proprietary assay for RA on a major laboratory system. We believe this will help to address the growing demand for the anti-CCP test in the important American market and allow larger volume batch testing. Rheumatoid arthritis is a potentially debilitating disease and early disease diagnosis facilitates improved treatment options and offers substantial patient benefits."
Enquiries:
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Axis-Shield plc |
Tel: +44 (0)2031787849 |
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Ian Gilham, Chief Executive Officer |
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Ronny Hermansen, Finance Director |
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Financial Dynamics |
Tel: +44 (0)207 831 3113 |
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Jonathan Birt /Mo Noonan |
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Notes to Editors:
About Axis-Shield
Axis-Shield is an international in vitro diagnostics company, headquartered in Dundee with R&D and manufacturing bases in Dundee and Oslo. The Group specialises in the supply of instruments and tests for the rapidly growing physician's office testing market and the development, manufacture and marketing of innovative proprietary diagnostics kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes.
For more information on Axis-Shield, please refer to www.axis-shield.com
This information is provided by RNS
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