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.
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.
The in-home kit is identical to the company’s oral rapid swab test, which is widely used by clinics, hospitals and other health-care providers. But studies showed that the in-home version was less accurate when used by consumers, with a 93 percent accuracy, compared with over 99 percent accuracy when used by trained professionals.
Positive in-home results need a supplemental test to confirm diagnosis. The company said the test might not be effective in the first three months after infection because it takes time for antibodies to build up.
Several panel members spoke about the need to improve labeling and give information to consumers in plain, understandable English. Company officials said 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 for customer support.
The cost of the in-home test will be a key factor in use, panel members said, but company officials declined to say what they will charge. The company’s chief medical officer, Stephen Lee, said the in-home kit will cost “substantially less” than the $60 to $70 charged for an FDA-approved HIV collection kit, which allows consumers to collect a blood sample at home that must then be sent out to a lab for test results. OraSure sells the professional version of its oral swab test for $17.50. But company executives said the in-home kit requires more extensive labeling and has to cover the costs of the customer call center.
Nearly all of the about 25 people who spoke Tuesday said they supported the test. Several had a financial relationship with OraSure, receiving grants for clinics or travel and hotel expenses. The speakers, including several living with HIV, emphasized the importance of increased testing, especially among high-risk groups and those hardest hit by HIV/AIDS, such as African American men and men who have sex with men.
Calvin Butts, pastor of the largest Baptist church in New York and chairman of the National Black Leadership Commission on AIDS, said he could envision a parishioner saying to him, “ ‘Pastor, will you sit 20 minutes with me while I take the test?’ ”
Dawn Averitt Bridge, 43, who has been living with HIV for 24 years and has two healthy, uninfected daughters, told the panel that women especially needed to have access to as many forms of testing as possible.
“We need to normalize testing, and this tool empowers users in a very important way,” she said.
Kimberly Crump of the HIV Medicine Association, a group of health-care providers and researchers, was the only speaker to caution against the test Tuesday, citing concerns about accuracy. She said the group would support the test when its accuracy improved.
Public health officials say they support all strategies that would expand access to HIV testing, including an over-the-counter home test. But they worry that a test without medical support and referrals could lead someone to delay or opt out of treatment.
“One of the caveats that is really important for the FDA and OraSure to consider is linking people who are HIV-positive to quality medical care and assuring that they get there,” Natalie Cramer, director of prevention for the National Alliance of State & Territorial AIDS Directors, which represents HIV/AIDS programs run by state public health departments, said Monday.
In the District — where at least 3 percent of residents have HIV or AIDS, a prevalence rate that is the highest of any U.S. city — free HIV testing is available at more than 40 clinics and other community providers, including one office of the Department of Motor Vehicles. The city has rapid-enrollment programs, such as Whitman-Walker’s “red carpet” program, which tries to link anyone who tests positive for the virus to the full range of medical services within 72 hours.
In a clinical trial conducted by the company, the test was 99 percent accurate in identifying HIV-negative people, but only 93 percent accurate in identifying those who were HIV-postive.
Company officials said their evaluation of all the tests point to an overall benefit for consumers. For every 1 million people who use the product, an additional 9,000 HIV-positive individuals would be identified, Michels said. Because people who know their HIV status are more likely to seek treatment or otherwise modify their behavior, that 9,000, he estimated, “will translate into at least 700 fewer forward transmissions” a year.