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OraSure Preparing to Seek FDA Approval for Nonprescription Sales of OraQuick Oral Rapid HIV Test

April 5, 2007

Bethlehem, Pa.-based OraSure Technologies during the past year has been preparing to seek FDA approval for nonprescription sales of its OraQuick Advance Rapid HIV 1/2 Antibody Test, the Allentown Morning Call reports. OraSure on Monday announced it has hired Durham, N.C.-based Constella Group to design a consumer counseling and referral system to accompany nonprescription sales of the test (Kennedy, Allentown Morning Call, 4/3). 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 (Kaiser Daily HIV/AIDS Report, 9/29/06). According to the Morning Call, the counseling and referral system will be a critical component FDA considers when deciding whether to approve OraQuick for nonprescription sales. The test currently is approved only for use by hospitals, physician offices and clinics (Allentown Morning Call, 4/3). The FDA Blood Products Advisory Committee at a March 2006 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 for nonprescription sales. 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, 9/29/06). OraSure in response to the FDA recommendation has conducted laboratory and label comprehension studies. The company plans to apply for FDA approval for nonprescription sales after additional clinical studies scheduled through 2008 are completed. The cost of the clinical studies is expected to be about $10 million, according to OraSure CEO Douglas Michels. According to the Morning Call, terms of the deal with Constella, which since 2002 has operated a nationwide HIV/AIDS call center for CDC, were not disclosed. Chris LeGrand, president of Constella's public sector business, said the company is "committed to helping individuals both understand their HIV test results and receive immediate information on accessing lifesaving treatment and care services" (Allentown Morning Call, 4/3).

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