Advisory Committee to Review OTC HIV Test

When FDA’s Blood Products Advisory Committee meets next week, it is expected to offer crucial insight about the necessary steps for moving an HIV test to over-the-counter status, a subject of debate of at least 10 years.

    OraSure Technologies Inc. wants to make its OraQuick Advance, which screens for HIV strains 1 and 2, available for people to test themselves at home. The company is hoping the committee will provide insight on what it would look for if OraSure submitted an application for over-the-counter status.

    “We are eager to hear their views,” said Douglas Michels, company president and chief executive officer.

    The 20-minute OraQuick test, which involves swabbing the gums with a pad that binds HIV antibodies in saliva, was approved for clinical use in March 2004. An earlier OraSure product that detected only one strain of HIV was approved in 2002.

Why OTC?

FDA has discussed over-the-counter HIV diagnostic techniques on several previous occasions, starting in 1998. In 1996 it approved a home collection kit manufactured by Direct Access Diagnostics, a Johnson & Johnson subsidiary, which allowed people to send blood samples through the mail for testing and receive their results over the phone. Other similar collection kits were approved later.

    But OraSure wants to make HIV test results available at home as quickly as they are in a medical office.

    “We’re not seeing a decline in the infection rate, despite the fact that there are more screening programs today than ever,” Michels said. “We’d love to see a day where everyone know their HIV status.”

    Freya Spielberg, co-coodinator of prevention interventions at University of Washington’s Center for AIDS Research and assistant professor of family medicine, said at-home testing is the next step in decreasing the infection rate. She said that 200,000 to 300,000 people in the United States are infected without knowing their status and she believes allowing people to test themselves will decrease this number.

“It’s clear that we need a new strategy to diagnose HIV,” she said.

    At-home rapid tests would be especially beneficial for people without health insurance or those who feel that there is a stigma attached to getting tested, she said.

Issues To Address

Based on previous discussions of home testing, and approval of the home collection kits, the advisory committee will likely raise a number of issues.

Accuracy

First, the manufacturer would have to demonstrate that people could use the test correctly and obtain accurate results. (For its 2004 approval, the test demonstrated greater than 99 percent accuracy at predicting HIV infection).

 Michels noted that OraSure has already conducted trials in which participants administered the test on themselves. Moreover, in June 2004 FDA allowed the OraQuick Advance test to be administered in non-laboratory settings, such as doctors’ offices and public health clinics under a waiver from the Clinical Laboratory Improvement Amendments that regulate non-research human testing.

But the company will probably have to design further trials and prove that home tests are as accurate as those given in clinical settings.

    OraSure is “looking to FDA for guidance on what additional proof they might need,” Michels said.

Support

The company would also have to provide adequate resources for people with positive test results, including counseling and medical referrals, Spielberg said. She suggested a 24-hour hotline to provide these services, in addition to an informational Web site.

    The company believes it’s essential that users know, when they purchase the product, how to access help for using the test, interpreting results, and finding appropriate care, Michels said. He noted that rapid test results are preliminary, and it will be necessary for those who test positive to understand that they must confirm the results with a medical caregiver. Michels added that pre- and post-test counseling would be available to users.

    An assessment of the home collection kits, which were approved in 1996, in the Nov. 18, 1998 issue of Journal of the American Medical Association, found the majority of people who tested positive after using these kits accepted referrals. According to data analyzed by Bernard Branson, of the Centers for Disease Control, 65 percent of people who tested positive accepted medical referrals. An additional 23 percent said they had other sources for follow-up medical care. Of the 610 people included in the data one expressed suicidal thoughts.

    According to Spielberg’s research in a group of 240-HIV positive people, 61 percent said they would have preferred to learn their status from an at-home test and more than 80 percent favored making these tests available.

Education

Another issue, Spielberg said, would be making sure people clearly understand the “window period” when HIV can be successfully detected. If people test too soon after they are potentially exposed to the virus, the antibodies will not be detected. As part of the approval process, OraSure will need to demonstrate that people understand this, she said.

    Michels indicated that OraSure would include this type of information in the package. It would also be feature in the product’s public awareness campaign, probably including a Web site.