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New test for rheumatoid arthritis marker receives FDA clearance

  [ 24 votes ]   [ Discuss This Article ] • October 17, 2009

“CCP antibodies may occur in the blood long before the onset of symptoms.”

Axis-Shield plc, an international in vitro diagnostics company based in Dundee, Scotland, has received marketing clearance from the 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 analyzers.

Rheumatoid Arthritis (RA) is a chronic autoimmune disease characterized 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 recognizing antibodies to cyclic citrullinated peptides (anti-CCP) 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 U.S. 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 [October 2009].

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.”

Source: Axis-Shield, plc news release (with modifications), Oct 16, 2009

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