GAITHERSBURG, Maryland - 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 US advisory panel has heard.
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 was easy, 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 Bethlehem, Pennsylvania-based company is considering seeking US FDA approval for its OraQuick test, which is already sold for use by doctors and other health-care providers.
No company has sought permission yet to sell the products in the United States but the FDA is asking the panelists for their advice as it weighs what criteria to use when considering such proposals in the future.
Agency officials said there were a number of concerns about at-home HIV tests, including how patients would cope with their results, especially people 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.
The FDA has been grappling with possible home-use HIV tests since 1986, when manufacturers first told regulators they were interested in selling kits that would allow people to collect a blood sample at home and mail it to a laboratory.
Several such tests have already been approved for HIV as well as hepatitis C.
Orasure's kit would allow a person to take a swab of saliva and insert it into a small bottle, providing the results while the patient waits at home.
Company officials said its HIV test had been proven effective, but they would conduct more studies on how well average people can interpret it on their own. Michels had no comment on when Orasure would file for approval, but said the studies would have to be done first.
The company has not said how it would charge consumers, but the professional version costs between US$12 and US$17.
Canada's Medmira Inc. is also considering seeking US approval for its version, which uses a blood sample.
- REUTERS
GAITHERSBURG, Maryland - 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 US advisory panel has heard.
Testing kits that allow
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