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Axis-Shield wins FDA marketing clearance

In vitro diagnostic company Axis-Shield has received marketing clearance from the American Food and Drug Administration (FDA) for a key arthritis product.

FDA clearance for the anti-CCP product, which is used in the diagnosis of rheumatoid arthritis, is a major boost to the London-listed firm.

The product will be delivered through the Abbotts Architects family of automated immunoassay analysers and is already being tested in non-US markets.

Ian Gilham Axis-Shield chief executive said: “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.” 

Posted on: 16/10/2009


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