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OraSure Begins Trials on OraQuick Oral Rapid HIV Test To Seek FDA Approval for Nonprescription Sales of Product
OraSure Technologies on Wednesday announced it has launched studies of its oral OraQuick Advance Rapid HIV 1/2 Antibody Test as the initial phase to obtain FDA approval to sell the test without a prescription, the AP/Houston Chronicle reports (AP/Houston Chronicle, 9/27). The OraQuick 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 test result is negative and the person is HIV-negative, and two appear if the result is positive and the person is HIV-positive. Positive results require a follow-up test with a medical professional for confirmation. The FDA Blood Products Advisory Committee at a March hearing told OraSure it needs to devise a clinical study to test the accuracy and safety of OraQuick before moving forward with the approval process. The committee recommended a multiple-phase experiment of at-home HIV tests that explores whether people could perform the test correctly and what psychological risks exist for those who test HIV-positive (Kaiser Daily HIV/AIDS Report, 5/17). OraSure has launched a group of "stress" or "flex" tests designed to determine the effects of environmental and common household factors on the OraQuick's accuracy, the company said in a release. "We are extremely pleased to have started the initial studies to support our efforts to obtain FDA approval for an over-the-counter offering of our OraQuick test," Douglas Michels, OraSure president and CEO, said, adding, "We look forward to continuing our work with the FDA and other members of the health care community to make a home use rapid HIV test available in the United States." The company recently launched several related studies on the product and plans to launch more in the near future (OraSure release, 9/27).
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