FDA advisory committee recommends approval of over-the-counter, at-home HIV test

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The following is a guest blog post by HIV Medicine Association Policy Officer, Kimberly Crump.

The U.S. Food and Drug Administration’s (FDA’s) 17-member Blood Products Advisory Committee voted unanimously to recommend FDA approval of OraSure Technologies’ over-the-counter, in-home HIV test Tuesday.

A woman demonstrates the use of the OraQuick rapid HIV test. (Photo Courtesy: Agência Brasil, a public Brazilian news agency).

After a full day of presentations from the product manufacturer, FDA internal experts, the Centers for Disease Control and Prevention (CDC), and others – as well as testimony from more than 25 HIV/AIDS and public health organizations – the panel concluded that the test’s ability to detect new HIV infections, connect HIV-infected people with care and treatment services, and potentially reduce transmissions, outweighed the risks of potential false negative results.

The panel’s recommendations will now be considered by FDA regulators as they determine whether and how the product should be approved as the first-ever over-the-counter, in-home HIV test. The product is a consumer-based version of the professionally administered OraQuick Advance test, consisting of an oral swab rapid test that produces results within 20 minutes. The test is not intended to be taken until 90 days after an individual last had a possible exposure.  If approved, the company said it would expect the product to retail for less than $60. The test is currently available for health care providers at a cost of $17.50 per test.

Modeling suggested that more than 4,000 net new infections could be averted annually should the test be available to consumers, according to FDA officials, but the actual number would depend on how many individuals at high risk for HIV infection will use the test. The modeling attributed this reduction in new infections to a decrease in risky sexual behavior by those newly aware of their HIV serostatus, but does not take into account the potential reduction in transmission that would occur as those newly diagnosed achieve repressed viral loads by accessing antiretroviral therapy.  The FDA said clear labeling and instructional information about the limitations of the test could be a possible risk mitigation strategy.

A statement from The HIV Medicine Association (HIVMA), a professional society representing more than 5,000 HIV/AIDS care practitioners in the U.S. and abroad, strongly supported over-the-counter sales of the HIV rapid test as an important tool for increasing the number of people aware of their HIV status. But HIVMA was one of the few groups to express concerns regarding research data demonstrating that in-home use of the test lacked sufficient sensitivity to avoid false negative results. The efficacy rate for identifying those with HIV infection with in-home use of the test was 93 percent, compared to 99 percent accuracy for those with and without HIV infection when administered by a health professional.  According to the FDA, use of the test could identify 45,000 new infections annually, while 3,800 would receive false-negative results. False negatives are of particular concern because they leave HIV-infected individuals disconnected from HIV care and less likely to take precautions, raising the risk that they will engage in unprotected sex. HIVMA argued that further research should be conducted in high-risk communities and populations, to increase the efficacy rate of consumer-driven testing to at least the FDA standard of 95 percent.

Some FDA advisory committee members argued for strongly worded labeling warning about possible false results and procedures, and providing a toll-free hotline to link users with questions to healthcare professionals. Panel members urged OraSure to undertake post-marketing studies to ensure that the test is available to under-served populations in a manner that would link those who use the kit to healthcare services, including confirmatory tests at professional settings.

HIV/AIDS and public health community advocates, including the Black AIDS Institute, the National Association of People with AIDS, AIDS United, the National Latino Commission on AIDS, and numerous others (some of whom received financial support of some type from OraSure) argued that the public health benefits of making the test available outweighed the risks of false negatives. 

The FDA is expected to announce its decision later this year.

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