Fortune Examines Challenges for Over-the-Counter Approval of OraQuick Oral HIV Test
May 17, 2006
Fortune magazine in its May 29 edition examines the challenges OraSure Technologies faces in obtaining FDA approval for over-the-counter sales of its oral OraQuick Advance Rapid HIV 1/2 Antibody Test, which some analysts predict might not happen for 18 months (Simons, Fortune, 5/29). The OraQuick test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the test result is negative and the person is HIV-negative, and two appear if the result is positive and the person is HIV-positive. Positive results require a follow-up test with a medical professional for confirmation (Kaiser Daily HIV/AIDS Report, 4/12). OraSure in December 2005 experienced a "setback" in its bid for OTC sales of OraQuick when some of the tests administered in Los Angeles, New York City and San Francisco gave false positive results, Fortune reports. FDA determined the false positives were the result of a failure by health workers administering the tests to follow its instructions (Fortune, 5/29).
Clinical Studies, Follow-Up Needed
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2006 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.