Originally published October 17 2005
FDA will consider approving at-home HIV test
by Mike Adams, the Health Ranger, NaturalNews Editor
Orasure Technologies may soon apply to the FDA to see whether its at-home HIV test, OraQuick Advance Rapid HIV-1/2 Antibody Test, could be sold over-the-counter.
US federal drug regulators will consider allowing the first US sales of an at-home test for HIV, the virus that causes AIDS, The New York Times reported.
The proposal for the OraQuick Advance Rapid HIV-1/2 Antibody Test, made by OraSure Technologies of Bethlehem, Pa., is scheduled to be discussed Nov. 3 by a federal advisory board.
The company said that after the advisory board meeting it would likely apply formally to the US Food and Drug Administration for permission to sell the at-home HIV test over-the-counter.
Currently, the test is sold only to clinics and doctors and has proven effective, safe and easy to use, the Times reported.
The FDA would need to decide whether approving the test for at-home use is a good idea and whether ordinary people can understand the test's label well enough to use it themselves.
A 1987 application for an at-home HIV test was opposed by public health officials and AIDS advocates, who feared that an at-home test would lead to panic, widespread suicides and a rush to public health clinics, The Times reported.
However, improved drug treatments for AIDS now mean in many cases it's a chronic disease that can be managed for years.
That means that there's less risk that a diagnosis of HIV/AIDS might prompt people to commit suicide.
In addition, US federal officials are now more open to the idea that an at-home HIV test may help prevent the spread of the disease.
"If we're going to win the war against AIDS, we need to make HIV testing as easy as pregnancy testing," Dr. Freya Spielberg, a researcher at the Center for AIDS Research at the University of Washington, told the Times.
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