Axis-Shield receives FDA clearance for new anti-CCP assay

Released: Friday 9th September 2011

Dundee, Scotland, 26 August 2011. Axis-Shield plc (LSE: ASD, OSE: ASD) ("Axis-Shield", the "Company" or the "Group"), the international and innovative in vitro diagnostics company, today announces that a new version of the Company's anti-CCP ELISA kit for the diagnosis of rheumatoid arthritis has been cleared for use by the US Food and Drug Administration ("FDA") under the 510(k) procedure. The new kit increases the assay range and contains changed components for reduced manufacturing costs and improved margins.

Anti-CCP represents an important part of Axis-Shield's laboratory business as it becomes increasingly recognised as the definitive marker for the early recognition of rheumatoid arthritis, often before clinical symptoms are apparent. Axis-Shield has licensed the assay to a number of global partners for use on their high throughput laboratory analysers. Both the American College of Rheumatology and the European League Against Rheumatism have now adopted anti-CCP testing in the classification criteria for rheumatoid arthritis. In the first half of 2011 sales of Axis-Shield's anti-CCP assay contributed £2.3 million to Group revenues.

Commenting on today's announcement, Ian Gilham, Chief Executive Officer of Axis-Shield, said: "The clearance of our new anti-CCP assay by the FDA is further validation of Axis-Shield's strong track record of working closely with regulators to broaden our offering of high-margin diagnostics in areas of clinical need, both to the laboratory market and at the point of care."


For further enquiries, please contact:

Axis-Shield plc


Ian Gilham, Chief Executive Officer
Ronny Hermansen, Finance Director

Tel: +44 203 178 7849



Peter Laing / Emma Thompson / Claire Dickinson

Tel: +44 207 920 2330

Corporate Communications (Norway)


Geir Bjørlo / Håkon Rønning

Tel: +47 23 89 89 30


About Axis-Shield

Headquartered in Dundee with R&D and manufacturing facilities in Dundee and Oslo, Axis-Shield is a successful international and innovative company operating in faster growing segments of the in vitro diagnostics (IVD) market. Axis-Shield provides point-of-care testing via its Afinion and NycoCard® instruments and also serves the clinical laboratory market through the development of novel tests, particularly for the high throughput analysers of blue-chip original equipment manufacturers (OEMs). The Company has a strong franchise in the diabetes testing market and is developing a cholesterol/lipid panel for testing at the point of care using the Afinion™ platform, both major areas for future growth. Through its direct distribution business, Axis-Shield also markets its own and other third-party products including medical devices to end users in key markets including the USA, Germany, Switzerland, the UK and the Nordic region. For more information on Axis-Shield, please refer to

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