Trinity Biotech gets US approval for HIV test product

Dublin-based Trinity Biotech has received approval from the US Food and Drug Administration to market its HIV test product in…

Dublin-based Trinity Biotech has received approval from the US Food and Drug Administration to market its HIV test product in the US.

The company's shares on the US Nasdaq exchange increased by close to 40 per cent following the announcement of the approval, bring the company's market capitalisation to $180 million (€144 million).

The company is also listed on the Dublin exchange.

The Uni-Gold Recombigen HIV test detects antibodies to HIV in human serum, plasma or whole blood.

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The company says it is the first and only device to be approved for use with all three sample types.

The test is a simple one, similar to a pregnancy test although using blood rather than urine. The product produces a result in only 10 minutes.

The company, which had a turnover of approximately $67 million this year, believes there is a $40 million per annum market for the product in the US.

The product, which the company has been selling in Africa for $1.25 per unit for the past number of years, intends to sell the product for $10 per unit in the US.

Trinity was established 12 years ago and employs 620 people, of whom 320 work in Bray, Co Wicklow, where the HIV test was developed. It is expected to announce a profit of $6.5 million for 2003.