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OraSure HIV Test Inches Closer to FDA Approval

November 29, 2010

The Food and Drug Administration is in the final stages of reviewing a proposed over-the-counter version of the rapid HIV test available in hospitals and clinics, test-maker OraSure Technologies said recently. To gain approval, OraSure will at a minimum have to prove that consumers untrained in lab testing can correctly use the OraQuick Rapid HIV test. The final review includes an assessment of such unsupervised self-testing. OraSure said it expects the trial "will continue well into 2011." "We are extremely pleased to have approval to begin the final phase of studies to support our efforts to obtain FDA approval for an over-the-counter offering of our OraQuick HIV test," said Douglas A. Michels, the company's president and CEO.

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Excerpted from:
Morning Call (Allentown, PA)
11.23.2010; Spencer Soper




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