• Our Vision is to improve healthcare as a global provider of innovative and reliable diagnostic tests.
  • Our Mission is to identify and develop novel patentable diagnostic markers and technologies which can be commercialised to meet clinical needs, both in the laboratory and at the point of care.
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Rheumatoid Arthritis (RA) is a common, systemic autoimmune disease affecting between 0.5-1% of the adult population. Axis-Shield offers a definitive test for early detection of this debilitating disease through the measurement of antibodies to cyclic citrullinated peptides (anti-CCP).

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.  

Over the last few years a novel antibody has been described  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. The key points emerging from the Anti-CCP literature are as follows:

Anti-CCP Utilities
* 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 in Pre-clinical Disease
* Antibodies are detected in serum from individuals up to 14 years before the first clinical symptoms of RA
* Patients with high Anti-CCP titres appear to correlate strongly with erosive disease
* Can be used in clinical practice to assist in planning therapeutic strategy

Role of Anti-CCP in Pathogenesis of RA
* Strong correlation between HLA-DR4 (shared epitope) and Anti-CCP positivity
* Citrullinated antigens are present in inflamed synovia
* Anti-CCP antibodies also produced locally in the synovium
* Anti-CCP producing plasma cells isolated from synovium of RA (Rheumatoid Arthritis) patients

New classification criteria for rheumatoid arthritis (RA)were published in the September 2010 edition of  “Arthritis and Rheumatism” Vol. 62, No. 9, pp 2569–2581, by Aletaha et al. The revised criteria have been approved by the American College of Rheumatology (ACR) Board of Directors and the European League Against Rheumatism (EULAR) Executive Committee, signifying that the criteria set has been quantitatively validated using patient data, and it has undergone validation based on an external data set. This new classification criteria set for RA follows recommendations at the latest ACR Congress in 2009 and will allow clinicians to focus on the important need for earlier diagnosis and more effective early therapeutic intervention. The outcome of the new criteria means that ACPA (principally anti-CCP antibodies) testing has been added to the biochemical criteria for disease classification, in addition to the long established sole blood test, the relatively non-specific Rheumatoid Factor assay.

In a follow up editorial by Professors Cohen and Emery, the co-authors state: "Additionally, the developing science regarding the importance of antibodies to citrullinated proteins (CCP) in RA occurred subsequent to the last classification criteria, and it is clear that inclusion of this testing in updated criteria was critical. Furthermore there are several ongoing efforts in progress to provide primary care physicians with tools to recognise patients who need rapid, early referral and we believe these new classification criteria will be rapidly adopted in daily practice, and we look forward to their implementation in clinical trials."

This formally recognised the importance of testing for anti-CCP antibodies in the early detection of rheumatoid arthritis from the major global authorities on this potentially debilitating disease. Anti-CCP is a key marker for Axis-Shield's Laboratory Division and this inclusion reinforces the importance of protecting our IP on anti-CCP testing.

For more details on our Anti-CCP assay, please visit the Anti-CCP page.

Axis-Shield at a Glance

A pioneering organisation focused on the development and manufacturing of important and innovative in vitro diagnostic tests for use in clinical laboratories and at the point of care.

› More about our tests

Focus on Homocysteine

As a general marker of overall health status, few tests carry greater predictive weight than Homocysteine. The amount of Homocysteine in your blood is one of the best independent indicators of how healthy you are.

 

› Axis-Shield Homocysteine assays

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Diagnostics for the laboratory & the point of care in areas of clinical need including diabetes, cardiovascular & neurodegenerative disease, rheumatoid arthritis & infectious disease.