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FDA Considering Feasibility of Home-Use HIV TestAlthough HIV affects more than 1 million Americans, with 40,000 new cases added each year, the disease’s reputation is slowly evolving to that of a chronic disease rather than the death sentence it was in the 1980s. Sensing both a better psychological climate and an opportunity to promote the benefits of earlier detection, FDA is actively exploring the advisability of at-home testing for HIV—a subject it has wrestled with since 1986. Earlier this month, the agency’s blood products advisory panel met with representatives from OraSure Technologies Inc. (Bethlehem, PA) to consider the company’s OraQuick Advance Rapid HIV test as a potentially suitable candidate for at-home use.
OraSure’s CEO and president, Douglas A. Michels, said, “For whatever reason, too many people aren’t getting tested. They might be afraid to go to the clinic or enter into that discussion with their physician, but people have told us that if there was a test available that they could use in private, they would use it.”
The OraQuick test kit was approved by FDA in November 2002 and is available at doctors’ offices, hospitals, and clinics worldwide. The test uses saliva to detect the presence of HIV antibodies within 20 minutes. OraSure says the test is 99% accurate, but notes that it will not detect the virus if the person only recently acquired HIV because it takes several weeks for antibodies to appear. The company also recommends that a positive result with OraQuick be confirmed through a second test administered by a doctor, hospital, or public health clinic. FDA has long cautioned about the potential for misuse and misinterpretation of home-use tests for HIV, but the agency’s primary concern is the reaction an individual might have upon obtaining a positive result. When HIV/AIDS was perceived as a body-ravaging disease with ominous implications for life expectancy, agency officials worried that a person who learned of a positive test in the absence of professional support might experience untoward psychological reactions including panic and suicide ideation. Now that the disease can be better managed through drug therapies, FDA officials believe the risk of adverse emotional reactions is significantly diminished. In line with the development of the at-home test, OraSure is considering plans for a 24-hour live hotline with access to referral sources, an interactive Web site, and detailed labeling and information to be supplied with the kit. Since the introduction of OraQuick, 3 million kits have been sold. The kit for medical professionals sells for between $12 and $17. No pricing has been determined for a home-use version. If approved, OraQuick would be the first completely self-contained HIV test for home-use. Currently, only one HIV test is approved by FDA for home use. The test, manufactured by Home Health Testing, a division of AbDiagnostics Inc. (Melbourne, FL), uses a small, finger-stick blood sample. The sample must be sent off to the company’s laboratory, with telephone results available a few days later. The test kit costs about $60. MedMira Inc. (Halifax, NS, Canada) is also reportedly contemplating seeking FDA approval of its Reveal Rapid HIV Test for home-use testing. In considering the advisability of a consumer product, FDA states that today’s “improved test-kit technology may make it feasible to identify regulatory criteria for a home-use HIV test kit.” Although FDA’s blood products advisory panel is not expected to make specific recommendations regarding OraQuick, members are reportedly receptive to the concept of at-home testing. OraSure reports that it plans to continue discussions with FDA. These talks may lead to clinical trials of a home-use version of the test and, eventually, to an application for approval.
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