Anti-CCP test to diagnose rheumatoid arthritis gets US FDA approval: Axis-Shield

An assay for anti-CCP to test rheumatoid arthritis (RA) by Axis-Shield plc has been granted marketing approval in US.

Anti-CCP to test rheumatoid arthritis (RA) which received marketing clearance from the US Food and Drug Administration (FDA) is be to run on Abbott’s Architect® family of automated immunoassay analysers.

CCP or cyclic citrullinated peptides targetting antibody test is a new method in rheumatoid arthritis diagnosis.

The introduction of tests recognising antibodies to cyclic citrullinated peptides has caused a revolution in rheumatology.

Rheumatoid Arthritis (RA) 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.

“We believe this [anti-CCP to test rheumatoid arthritis] 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,” stated Ian Gilham, Axis-Shield CEO.

Rheumatoid Arthritis (RA) is a chronic autoimmune disease characterised by inflammation of the lining of the joints, causing pain and disability.

Rheumatoid Arthritis (RA) affects approximately one in every 100 people of all races and ethnic groups.

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 is planning to introduce the test in the USA later this month.

Axis-Shield is an international in vitro diagnostics company, headquartered in Dundee with R&D and manufacturing bases in Dundee and Oslo.  Axis-Shield 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 cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes.

Axis-Shield’s products include the NycoCard range and the state-of-the-art Afinion system.

Axis-Shield’s shares are traded on the London and Oslo Stock Exchanges and the group comprises Laboratory Division in Dundee, a Point-of-Care Division in Oslo and local distribution subsidiaries in the UK (Axis-Shield UK), in Norway, Sweden, Denmark and Finland (Medinor), Switzerland (Axis-Shield AG) and in Germany (Axis-Shield GmbH).

Cyclic citrullinated peptides (CCP) in RA
RA is characterised by inflammation of the synovial joints. This can lead to progressive joint destruction and consequently impair the quality of life. It is generally accepted that early intervention is vital in preventing irreversible joint damage and therefore it is important to diagnose RA as early in the disease course as possible.

Presently, the Rheumatoid Factor (RF) test is commonly used as a serological marker for RA, although it is accepted that the test lacks specificity and is also often absent in the disease (seronegative RA).

Over the last few years a novel antibody has been described and which is reported to have high very specificity (>95%) and sensitivity (80%) for RA. Antibodies to cyclic citrullinated peptides (Anti-CCP1) were first described in 1998 and following the introduction of commercial ELISA products employing the so-called second generation peptides (CCP2), there has been a plethora of publications in the last 2 years on the utility of this marker in the diagnosis of early RA.

Anti-CCP Utilities help accurate diagnosis of RA in early synovitis patients ;    differentiation of RA from other inflammatory arthritides; differential diagnosis of RA from other connective tissue disease such as erosive SLE ;confirmation of diagnosis in seronegative Rheumatoid Arthritis (RA).

Anti-CCP antibodies are detected in serum from individuals up to 14 years before the first clinical symptoms of RA.