Cortecs blood kit approved in US

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The Independent Online
Cortecs International, the fledgling biotechnology group, took another step towards maturity yesterday after announcing it had received US approval for its rapid blood diagnostic kit.

The shares gained 9p to 369p as the green light from the powerful Food & Drug Administration opens up the world's largest market for the Helisal kits, which test for the presence of Helicobacter pylori, the bug associated with duodenal and gastric ulcers.

H. pylori is carried by around a third of the world's population and although most do not show any symptoms, it is now known to be the most common cause of gastritis and peptic ulcers, the company says. It has also been linked with stomach cancer and heart disease and branded a "class- one carcinogen" by the World Health Organisation.

Using a pin-prick blood sample given in a doctor's surgery, Helisal can within five minutes give a test for the bacteria equivalent to that available from a laboratory, Cortecs claims. Once the bug has been identified, duodenal ulcers can be treated relatively rapidly with drugs like Astra's Losec. The market for the kit is worth an estimated $100m to $150m, the company believes.

Cortecs has been selling the kits in the UK for the past two years and they are now said to be generating a "seven-figure" turnover. It has also been launched in around 25 countries around the world following the signature of a marketing deal with Boehringer Mannheim, a German pharmaceutical group, which will also handle sales of Helisal in the US. However, it faces competition from two domestic producers of rival kits, including one marketed by Abbott Diagnostics. Cortecs hopes to have a second-generation, single-step kit on the market later this year and wants to introduce a non-invasive product based on saliva. It is also working on tests for osteoporosis and diabetes.

Separately, Chiroscience announced shareholders had taken up 78.7 per cent of the shares offered in its recent pounds 40.3m placing and open offer.