Axis-Shield plc (LSE:ASD, OSE:ASD), the international in vitro diagnostics (IVD) company, today announces that The National Institute for Health and Clinical Excellence (NICE) the independent organisation sponsored by the UK Department of Health, charged with responsibility for providing national guidance on the promotion of good health and the prevention and treatment of ill health, has issued new guidelines on the management of rheumatoid arthritis in adults which encourage wider use of anti-CCP antibody testing. The guidelines were published by the Royal College of Physicians yesterday on behalf of the National Collaborating Centre for Chronic Conditions, which is funded to produce guidelines for the NHS by NICE.
One of the conclusions from the report from the Guideline Development Group (GDG) states that antibodies against cyclic citrullinated peptides (anti-CCP) have emerged in recent years as being equally as sensitive, but more specific, than rheumatoid factors in the diagnosis of RA. In an algorithm for investigating new patients with signs of RA-like symptoms, the guideline recommends that the measurement of anti-CCP antibodies should be considered in those people suspected of RA who are negative for rheumatoid factor and in whom there is need for informed decision making relating to the initiation of combination therapy. The report also mentions that anti-CCP appears to add information above and beyond testing for rheumatoid factor (RF) as far as prognosis is concerned and that a combination of both RF and anti-CCP positivity is associated with particularly poor prognosis.
The principal strength of anti-CCP antibodies appears to be in people who are negative for rheumatoid factor where an anti-CCP test can be helpful both for diagnosis and prognosis. Discussion in the GDG report also suggests that an anti-CCP test is useful in people who are positive for rheumatoid factor, but where the clinical picture is not suggestive of RA. A positive anti-CCP test under these circumstances would suggest that this individual is at risk of developing RA subsequently, and should be followed up closely. However, as there are currently only limited data (clinical and cost-effectiveness) available in this group of patients, the GDG concluded that a formal recommendation would be premature.
Doris-Ann Williams, Director General of BIVDA, the British trade association for companies supplying in vitro diagnostic products, commented: "NICE is now considering evaluation procedures for medical technologies including diagnostics, recognising the potentially important role played by IVDs in healthcare. I believe NICE recommendations are carrying increasingly significant weight in medical practice."
Ian Gilham, Axis-Shield CEO, further commented: "These guidelines from NICE confirm the importance of testing for anti-CCP antibodies in the management of this debilitating disease and the clear benefits for patients by early detection of their presence. Axis-Shield's anti-CCP assays have been demonstrating rapid growth in recent years and we anticipate that the NICE guidelines issued yesterday will encourage wider utilisation of this test in the UK. This confirmation of test utility also adds weight to the drive to expand the use of anti-CCP testing for RA in other international markets."
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.
Axis-Shield
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