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Health and medicine
Panel considers home test for the AIDS virus
Associated Press
Published November 4, 2005
WASHINGTON - Tom Donahue, 26 years old, learned two years ago he had the virus that causes AIDS.
He told government medical advisers Thursday he had learned from a family doctor in State College, Pa., that he had tested positive for HIV. But he worries that too many people are afraid of going to clinics to get tested because others may find out.
"I live in a community surrounded by students and stigma," he said.
Donahue implored a federal panel to speed approval of the first HIV test that can be taken entirely at home, saying it will lead to more people learning sooner they have the disease.
The test, called OraQuick Advance, is made by OraSure Technology, of Bethlehem, Pa. It is already widely available in health clinics and doctors' offices, and the FDA is considering permitting it to be sold over the counter.
The government panel, the Food and Drug Administration's Blood Products Advisory Committee, heard opinions on whether the test should be made available over the counter.
An FDA scientist said the privacy and convenience of the test is a potential boon in that it could lead to more people seeking treatment earlier during the course of the illness, but the agency needs more information before it can be approved for sales directly to the public.
"Anonymous testing potentially leads to more people knowing their HIV status," Elliot P. Cowan, a product review chief at the agency, told the committee.
Still, Cowan raised a number of concerns to the panel, a group of independent experts who can recommend to the FDA whether to approve the product. The panel was not asked to make such a recommendation Thursday but may in a future meeting, and the final decision ultimately rests with the FDA.
The possible availability of the test, which relies on a swab of the inside of the mouth, has raised concerns about the potential psychological impact on people who learn they have the virus with no doctors or counselors present.
[Last modified November 4, 2005, 01:42:07]
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