May 15, 2012 -- The FDA should approve the first HIV test for at-home use and over-the-counter sale, the agency's advisory committee said today in a unanimous 17-0 vote.
The test is OraQuick from OraSure. It's a home version of a rapid HIV test already being used by health care professionals in community settings.
The committee's opinion was summed up by panel member Steven W. Pipe, MD, of the University of Michigan.
"I can't get past the quarter of a million people in the U.S. who have HIV and are not tested," Pipe said at the meeting. "If we make any dent in that, the answer is yes, we realize the [OraQuick At-Home] benefit outweighs its risks."
The price tag of the at-home test has not yet been set but will be a good bit more than the $20 cost of the professional version. That's partly because it will come with a detailed instruction booklet, and because OraSure will set up a call center with trained counselors available 24 hours a day, seven days a week.
"The price will be substantially lower than $60," Stephen R. Lee, PhD, OraSure executive vice president and chief science officer, told the committee.
Now anybody concerned about whether they have the AIDS virus -- and who can afford OraQuick -- may be able to take the test at home. But there's a catch.
In clinical trials enrolling regular people at risk of HIV infection, some 7% of people with HIV infection are wrongly told they don't have HIV. With a professional test, that happens only 2% of the time.
According to FDA calculations, this means that in the first year after approval, the test will wrongly tell about 3,800 people with HIV infection that they are not infected.
The FDA calculates that in the first year after OraQuick is approved for home use, an extra 45,000 people will correctly learn they have HIV.
That's a big deal. The CDC estimates that there are 50,000 new HIV infections every year. About 1.2 million Americans are HIV-infected, and about 1 out of 5 don't know they carry the AIDS virus. Such people may be more likely to spread the virus than those who know they are infected.