Axis-Shield wins green light to sell arthritis test in US

AMERICA'S Food and Drug Administration has given Dundee-based Axis-Shield the go-ahead to sell one of its key medical testing products in the United States.

The company's rheumatoid arthritis test, which runs on a diagnostic system made by New York-listed Bio-Rad Laboratories, is already on sale in countries outside North America.

Ian Gilham, Axis-Shield's chief executive, said: "FDA market clearance for the test on Bio-Rad's system represents an important milestone in the commercialisation of this marker for rheumatoid arthritis."

Gilham believes the launch in the US will help to grow the market for similar products as much the same technology can be used to diagnose other conditions.

John Goetz, Bio-Rad vice-president and group manager of clinical diagnostics, said: "We believe the recent recommendation by the American College of Rheumatology and the European League Against Rheumatism to include this type of test in the definitive diagnosis of rheumatoid arthritis will further establish the growth of this important marker in autoimmune diagnostics."

The announcement is the latest in a string of positive statements from the Scots company, which issued a profits warning in May following a "poor" flu season in which it sold fewer testing kits than it had expected.

Shares fell by 23 per cent on the day of the warning but have recovered ground over the summer.

Mike Mitchell, a healthcare analyst at Seymour Pierce, pointed out that similar testing kits had generated sales of 4.5 million for Axis-Shield last year.

Revenues in 2009 hit 96.7m, up from 85.3m the previous year, with the firm's bottom line swinging from a 4m loss to a 11m profit.

Mitchell added: "We view this news as another step forward for the team, which has been rebuilding its track-record since May's 'wobble'.