Trinity seeks FDA approval to market HIV test for home use

By Lisa Kerner

Erie, Pa., March 9 - Trinity Biotech plc is requesting a meeting with the Food and Drug Administration to discuss FDA marketing clearance for over-the-counter sales of the company's UniGold HIV test.

Trinity's UniGold HIV test is one of only two products which are FDA approved and CLIA waived to be marketed to hospitals, reference laboratories, physicians' offices, public health clinics and community-based organizations, according to a company news release.

The approval to distribute over the counter would allow individuals to purchase the UniGold test in a drugstore and test themselves for HIV in the privacy of their own homes, the company said.

The UniGold HIV test uses a fingerstick, a membrane containing HIV antigens and a color indicator. Results are available within 10 minutes.

Trinity said in clinical trials of 9,000 patient samples, the UniGold device detected a true positive reading 100% of the time, with a true negative detection rate of 99.7%.

"We believe the time is now right for the home use of rapid HIV tests," president Brendan Farrell said in the release.

"Approximately 1.3 million Americans are infected with HIV and it is estimated that 300,000 of these people are unaware of their status.

Trinity will present its position on home testing for HIV at a meeting of the Blood Products Advisory Committee of the FDA on March 10.

Trinity develops, acquires, manufactures and markets over 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The company is located in Dublin, Ireland.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.