Home HIV test should be approved, FDA panel rules

An expert panel recommended Tuesday that the Food and Drug Administration approve the first over-the-counter HIV test, a kit that could quickly return results for consumers in the privacy of their homes.

The unanimous votes by a 17-member advisory panel, if accepted by the FDA, would broaden testing options for the virus that causes AIDS, providing an important additional tool for many Americans who are reluctant to get tested, public health officials and advocates said. The test uses a mouth swab to detect the presence of antibodies to the virus within about 20 minutes.

(AP) - The OraSure in-home test is identical to the company’s oral rapid swab test widely used by clinics, hospitals and other health-care providers (shown above), according to Doug Michels, chief executive of the manufacturer, OraSure Technologies. But the in-home version has simplified instructions, pictures to help consumers understand how to use the kit and interpret results, and a 24-hour, toll-free telephone number to a customer support center, he said.

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The Senate Subcommittee on Primary Health and Aging held hearings to examine the cost of HIV/AIDS drugs Tuesday. Mohammad Akhter, a former executive director of the American Public Health Association, says current prices are not affordable.

Although speakers and FDA officials had raised concerns about the accuracy of the test, the members said identifying new infections and averting transmissions outweigh the risks of missing some people who are infected.

“I think the information suggests that this test could be very significant in helping to stem the number of new cases of HIV that occur every year,” said Blaine Hollinger, a Baylor College professor of medicine and chair of the panel.

Richard Forshee, associate director for research in the FDA’s office of biostatistics and epidemiology, said the test could potentially identify 45,000 new individuals per year who are infected and avert more than 4,000 HIV transmissions annually in the United States. But he estimated the test would also miss about 3,800 HIV-positive people per year.

Early HIV testing and treatment are key to reducing the spread of the disease, officials say.

An estimated 1.2 million people in the United States are living with HIV infection, according to the Centers for Disease Control and Prevention. One in five of those people is unaware of his or her infection. About 50,000 Americans become infected each year, a number that has remained steady for the past decade.

Last week, another FDA panel recommended that the agency approve, for the first time, a drug to give to healthy but at-risk people to protect against the infection.

FDA officials declined to comment on when the agency would make a final decision on the home test. But executives for the manufacturer, OraSure Technologies, said they expect action this summer. The company’s chief executive, Doug Michels, said he was “delighted” with the committee vote. He said the company will work with the agency to incorporate the feedback from the panel members about improvements to labeling and instructions for use.

The FDA usually follows the advice of its advisory committees, made up of experts from outside the agency, although it does not have to.

Public health officials said it is hard to predict who might use the test.

“There are many unanswered questions about the use of the tests: Who are the people who would use them, how they would use them and how the results would be acted on” in terms of modifying behavior and seeking care, Amy Lansky, deputy director of epidemiology at the CDC, told the panel. “These factors need to be considered.”

A national poll conducted last spring by the Kaiser Family Foundation found that 44 percent of Americans between ages 18 and 65 said they had never been tested for HIV. Asked to list reasons why they had not been tested, 64 percent said they did not believe they were at risk of contracting HIV, 29 percent said their doctor had never recommended testing and 12 percent said they did not know where to go for testing.