Wall Street Journal Examines OraQuick Oral HIV Test as At-Home Test
April 12, 2006
The Wall Street Journal on Wednesday examined Bethlehem, Pa.-based OraSure Technologies' oral OraQuick Advance Rapid HIV 1/2 Antibody Test and the company's goal to make it available for at-home use (Koons, Wall Street Journal, 4/12). The oral test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the HIV result is negative, and two appear if the result is positive (Kaiser Daily HIV/AIDS Report, 3/14). Positive results require a follow-up test for confirmation (Wall Street Journal, 4/12). The FDA Blood Products Advisory Committee in a public hearing last month told OraSure that it needs to devise a clinical study to test the accuracy and safety of OraQuick before moving forward with the federal approval process. The committee recommended a multiple-phase experiment of at-home HIV tests, which would explore whether people could perform the test correctly and what psychological risks exist for those who test HIV-positive. OraSure CEO Douglas Michels has said he expects to launch the studies this summer (Kaiser Daily HIV/AIDS Report, 3/14). He said, "The studies will be designed to validate the ability of an untrained user to perform the test, to understand the instructions for use, to interpret the test result correctly and be able to follow the instructions after they've conducted the test" (Wall Street Journal, 4/12). Michels has said he does not yet know when the trials will conclude. FDA will determine the next steps in the approval process for at-home HIV testing after the study is completed (Kaiser Daily HIV/AIDS Report, 3/14). Analysts think the launch of the at-home test still is at least one year away, but making the test available "appears a priority at the federal level," the Journal reports. Bernard Branson, CDC's associate director of the HIV/AIDS division of Lab Diagnostics, said, "We think there is a likely place for [at-home] testing. We have observed during the FDA hearings and other times that there appears to be strong community support," adding, "But we want to be sure that (the tests) are safe and effective" (Wall Street Journal, 4/12). OraQuick has been proven accurate, despite recent reports of false-positive results, Michels said in January. He added that the accuracy rate is in line with what is printed on the product's label and said that reports of higher-than-expected false positives are limited to a few sites and likely are unrelated to particular test lots (Kaiser Daily HIV/AIDS Report, 1/13).