Pretty soon there will be no excuse for not knowing your status—not that there’s much of one now.
A 17-member FDA panel just voted unanimously that OraSure Technologies’ over-the-counter, at-home HIV test is reasonably safe and effective for determining whether someone has the AIDS virus. In saying so, the panelist agreed that the test’s ability to prevent new HIV infections and provide HIV-positive people with access to medical care and social services outweighed the risks of potential false results. The panel’s recommendation will now be taken into consideration by the agency’s regulators as they decide whether the OraQuick Advance In-Home HIV Test should be approved as the first over-the-counter, completely in-home HIV test.
The new product is an oral swab rapid test that produces results within 20 minutes and shouldn’t be taken until 90 days after an individual’s last risky behavior. If approved and marketed over the next several months, the company said it would expect the product to retail for less than $60. That price tag could still be a bit much for those who need it most which is why panel members urged OraSure to undertake post-marketing studies to ensure that the test is available to under-served populations and that those who use the kit receive follow-up healthcare services including confirmatory tests in professional settings.
One caveat of this breakthrough is that some research data suggested the test lacked sufficient sensitivity to avoid false negative results. This could be particularly dangerous if individuals who are actually HIV-positive receive a negative result and engage in risky behavior. For that reason, panel members are pushing for strongly worded labeling about false results and procedures to link those who telephone a company hotline with questions with healthcare professionals.
This news on top of the FDA panel’s recommendation of regulatory approval for Gilead Sciences Inc’s HIV drug, Truvada, as the first pill treatment for protecting uninfected individuals last week, shows promise for reducing HIV infections in the future, which is definitely overdue.
What do you think about this at-home test? Would you use it?
Brande Victorian is a blogger and culture writer in New York City. Follower her on Twitter at @be_vic.
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