FDA Panel Ponders Home HIV Test
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The pros and cons of a simple home-use HIV test were the focus of 10 hours of testimony at an FDA advisory committee meeting yesterday. Now the company that makes the test is talking to the FDA about the next step.
The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, developed by OraSure Technologies Inc, of Bethlehem, Pa., won FDA approval in March 2004—but not for home use.
Most HIV tests require blood samples, but the OraQuick test relies on antibodies found in oral fluid specimens. The person using the test swabs the outer gums with the test device and places the swab in a container provided as part of the kit. The result appears within 20 minutes.
Doug Michels, president of OraSure, declined to speculate on when a marketing application might be submitted, but he called the hearings “extremely valuable.” He said the company expects to continue meetings with the FDA over the next few weeks.
The members of the Blood Products Advisory Committee panel made no recommendation, nor were they expected to do so, said an FDA spokeswoman. Instead, the panel was trying to see what issues a simple home HIV test might raise, and how they might be addressed. “It was not so much fact-finding as raising issues,” she said.
The ball is now in OraSure’s court, she added. If the company submits a marketing application, “we would engage in discussions with them.”
About one million people in the United States have HIV, according to the CDC, which estimates that about a quarter of those are unaware of it.
One hurdle that company would have to pass, she said, would be clinical studies to make sure the test performs as well in the home setting with an untrained user as it has done in the lab.
Late in 2004, OraSure was granted a Clinical Laboratory Improvement Amendments (CLIA) waiver, meaning it was sufficiently simple and accurate that it could be used in a wide variety of settings, including doctor’s offices and health clinics.
Currently, all rapid HIV tests are categorized as restricted devices, which can only be sold to clinical laboratories. Participants must get an information pamphlet before the test and be given appropriate counseling when the results are provided.
According to pre-hearing briefing documents posted online by the advisory committee, any extension to home use has pros and cons.
Benefits include anonymous testing. On the other hand, a home user might misuse the test by, for instance, taking it too soon after an exposure, leading to a false-negative result.
Also, current practice involves counseling—something that wouldn’t be available immediately to home users—and notification of partners, which a home user might not do.
The committee said additional issues include:
- Possible use by minors.
- The possibility that home users might not get a supplemental blood test to confirm the diagnosis.
- The test might be too costly for those who need it most or might not be available for other reasons.
- State and federal health reporting might be compromised.
One other home test—the Home Access Express HIV-1 Test System, made by Home Access Health Corp., of Hoffman Estates, Ill.—is approved by the FDA. Those taking this test must take a sample themselves and mail it to a lab for results.
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