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FDA Approves OraSure Rapid HIV Test for Expanded Use With Blood Drawn Intravenously

September 11, 2003

The FDA has approved Bethlehem, Pa.-based OraSure Technologies' OraQuick HIV test for expanded use in hospitals using blood drawn intravenously and stored in a tube, the Allentown Morning Call reports. The test previously could be used only with blood obtained from a finger prick (Kennedy, Allentown Morning Call, 9/10). In February, President Bush announced a plan to expand the availability of the test, which offers results that are 99.6% accurate within 20 minutes, to more than 100,000 doctors' offices and public health clinics nationwide (Kaiser Daily HIV/AIDS Report, 6/24). While the finger-stick method is better suited for testing in clinics, the new approval "opens up the door to a greater portion of testing" because the method is better suited for hospitals, William Bruckner, OraSure's vice president of marketing, said, according to the Morning Call. He added that hospitals perform 12 million HIV tests annually, compared with 2.3 million performed each year in public health clinics (Allentown Morning Call, 9/10). OraSure also said it is finishing clinical trials examining the use of oral fluid and plasma samples with the OraQuick test and expects to seek FDA approval for the use of such fluids in the "near future," Reuters reports (Reuters, 9/9). According to an OraSure release, the company has filed for FDA approval for use of the OraQuick test to detect HIV-2, a less common type of HIV found mostly in West Africa (OraSure release, 9/9).

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