Trinity Biotech, the Co Wicklow-based manufacturer of diagnostic products, said the US Food & Drug Administration's Centre for Biologics Evaluation and Research (CBER) has granted an Investigational Device Exemption (IDE), for treatment use, for Trinity's Uni-Gold TM HIV Test.
This IDE allows Trinity Biotech's Uni-Gold TM HIV test to be used, in a number of hospitals throughout the US, to provide patients with the results of tests conducted during ongoing clinical trials.
Trinity's product would be used to provide diagnostic test results, in less than 15 minutes, in situations involving needle-stick injuries and pregnant women at high risk of HIV presenting for delivery, it said.
In response to the news the company's share price was trading 13 cents up on the Dublin Stock Exchange this morning.
AFP