Rheumatoid Arthritis Testing Kit Approved for U.S.
Posted Oct 17 2009 10:01pm
A rheumatoid arthritis (RA) diagnostic tool, made by Axis-Shield of Dundee, Scotland, has been approved for use in the United States by the U.S. Food and Drug Administration (FDA). Approval of the testing kit was announced Friday, October 16th by the FDA.
The kit is used to identify specific antibodies which show signs of RA before there are any symptoms.
Recent studies have shown that these antibodies to cyclic citrullinated peptides (anti-CCP) can be found in the blood well before the rheumatoid arthritis symptoms begin.
According to Axis-Shield chief executive Ian Gilham:
“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.”
Axis-Shield already has contracted for its anti-CCP product to be marketed in the US through Abbots Architect, an established brand of diagnostic test products.