An HIV test that can be used at home and promises results in 20 minutes could help more people get treated sooner, but raises concerns about how well patients could cope with the test findings on their own, a U.S. advisory panel heard on Thursday.
Testing kits that allow consumers to mail a blood sample to a laboratory for results have been approved in the past, but advocates said allowing people to find out their HIV status at home makes testing easier, faster and more private.
“A number of people don’t get tested because they are concerned about privacy,” Orasure Technology Inc. Chief Executive Douglas Michels told Reuters at the Food and Drug Administration panel meeting.
The company is considering seeking FDA approval for a home version of its OraQuick test, which is already marketed to doctors and other health-care providers.
No company has sought U.S. permission to sell the products over-the-counter, but the FDA is asking for the panelists’ advice as it weighs how to review future proposals.
Agency officials said there were several concerns about at-home HIV tests, including how people would cope with their results, especially those younger than 18.
“Concerns have been expressed over the years about the psychological effects of receiving a positive HIV test result without the benefit of counseling. The issue that has come up repeatedly is suicidal tendencies,” said Elliot Cowan, head of product reviews for the FDA’s Division of Emerging and Transfusion Transmitted Diseases.
OraQuick would allow consumers to insert a swab of saliva into a small bottle, providing the results while the patient waits at home. Like home pregnancy tests, various colored lines appear on a small window depending on whether the virus was detected.
The panel appeared to support marketing the test to consumers, and told the FDA it should require over-the-counter versions to perform almost as well as the professional ones.
“I would agree that we could probably lower the bar a little bit for the public health good,” said panelist Thomas Quinn, a professor of medicine at Johns Hopkins University in Baltimore, Maryland.
Companies considering U.S. approval should conduct studies that mimic home use, include minorities and teenagers, and explore what happens if people use the test incorrectly, the panelists recommended.
They should also include simple information about getting treatment and the need to get a second test to confirm the results, the panel said.
During the public hearing, a few opponents argued that HIV screenings should be left to trained professionals who could provide immediate advice.
Nearly a dozen activists and researchers said easier access would encourage more people, especially those without access to health care or those worried about being stigmatized, to get tested.
Over-the-counter tests are “a must in our fight against the spread of this disease,” said Rev. Richard Cizik, vice president for governmental affairs at the National Association of Evangelicals.
Orasure’s Michels said the company was working on what kind of information to include with its test. OraQuick is effective, but he said the company would conduct studies on how well average people can use it before filing for approval.
The next step is for the company to meet with the agency, he added.
He did not say what it would charge consumers, but the professional version costs between $12 and $17.
Canada’s Medmira Inc. is also considering seeking U.S. approval for its version, which uses a blood sample.
Revision date: July 6, 2011
Last revised: by Sebastian Scheller, MD, ScD