Policy & Politics
FDA Expands Use of OraQuick Rapid HIV Test to 180,000 Sites, Including Doctors' Offices, Clinics
June 28, 2004
FDA announced on Friday that Bethlehem, Pa.-based OraSure Technologies' OraQuick Rapid HIV-1/2 Test can be used in doctors' offices and HIV counseling centers in addition to certified laboratories, expanding the product's use of the test to approximately 180,000 sites, the AP/New York Times reports (AP/New York Times, 6/26). The test, which produces results in 20 minutes, works with blood from a finger stick or oral fluid collected from the gums of a patient's mouth using a treated swab. On Wednesday, the company announced that FDA had approved the OraQuick Rapid HIV-1/2 Test for use in detecting HIV-2 antibodies in oral samples. Although FDA already had approved the test to detect HIV-1 and HIV-2 in blood samples, it had approved the oral version of the test only for HIV-1 (Kaiser Daily HIV/AIDS Report, 6/25). The test previously was approved for use primarily in government-approved laboratories. However, following last week's approval of the test for detecting HIV-2 antibodies in oral fluid, the company "immediately" sought an FDA waiver to allow the oral fluid test to be used in clinics and doctors' offices, the Allentown Morning Call reports. OraSure President and CEO Douglas Michels said, "We believe this waiver represents the final step needed to make our new OraQuick HIV-1/2 Test the most versatile and comprehensive rapid HIV test available to the widest possible range of customers in the United States." The test is expected to go on the market in mid-August, according to the Morning Call (Shope, Allentown Morning Call, 6/26). HHS Secretary Tommy Thompson on Friday also announced that the federal government has allocated $4.8 million to the HHS Substance Abuse and Mental Health Administration to support expanded testing for HIV/AIDS among injection drug users and their sex partners, according to an HHS release (HHS release, 6/25).
This article was provided by Henry J. Kaiser Family Foundation. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.