Advertisement
The Body: The Complete HIV/AIDS Resource
Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App
Professionals >> Visit The Body PROThe Body en Espanol
Read Now: TheBodyPRO.com Covers AIDS 2014
  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

U.S. News

FDA Panel Backs OraSure's In-Home HIV Test

May 16, 2012

A panel of outside experts voted unanimously on Tuesday to recommend that the Food and Drug Administration approve OraSure Technologies Inc.'s OraQuick In-Home HIV Test. The 17-member FDA advisory committee said the benefits of people knowing their HIV status -- and seeking treatment, if positive -- outweigh the risks of false results.

If approved, OraQuick would be the first over-the-counter, at-home HIV test. OraSure said it will likely retail the test for less than $60.

Panel members called on the company to conduct post-marketing studies to ensure OraQuick is accessible by under-served populations in a way that links testers to services, including confirmatory follow-up for those who have a positive result. Some of the experts urged clear labeling about false results; another concern was linking consumers who phone OraQuick's hotline with questions to health care professionals

The panel heard supportive testimony from more than two-dozen witnesses including HIV/AIDS activists and representatives from the African-American community and public health. OraQuick could help eliminate HIV stigma, a key barrier to testing, by being available just like other home testing kits at a local pharmacy, they said. Some of those testifying received money or assistance from OraSure.

FDA officials said the test was highly effective at detecting HIV infection, but some data indicated OraQuick lacks sufficient sensitivity to avoid false-negative results. One witness called on the agency to withhold approval until additional studies can raise the test's accuracy to a standard in line with clinical settings.

Back to other news for May 2012

Adapted from:
Reuters
05.15.2012; David Morgan


  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
 
See Also
U.S. Panel Will Consider Home AIDS Test
Quiz: Are You at Risk for HIV?
10 Common Fears About HIV Transmission
More on Home HIV Testing

No comments have been made.
 

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:

Tools
 

Advertisement