The US Food & Drug Administration's Centre for Biologics Evaluation and Research has granted an Investigational Device Exemption, for treatment use, for Trinity Biotech's Uni-GoldTM HIV test.
This allows Uni-Gold 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.
Clinical data gathered during these trials will be submitted to the FDA as a supplement to the data already provided by Trinity Biotech in their PMA Application.
