OraSure Technologies Inc. said today it has begun studies on its rapid test for HIV for use at home.
The Bethlehem company said it will seek Food and Drug Administration approval to sell the 20-minute HIV test over the counter. If approved, the OraQuick test would be the first at-home diagnostics test for HIV, similar to a home pregnancy test.
OraSure shares were up 3.70 percent, or 30 cents, to $8.30 in late morning trading on the Nasdaq.
The company is conducting laboratory-based studies, and plans additional clinical studies under an investigational device exemption filed with the FDA to use its device in safety and effectiveness studies to support regulatory approval.
OraSure president and chief executive officer Douglas A. Michels said, "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."
In November 2005, an FDA advisory panel met in Gaithersburg, Md., to discuss HIV home tests. The FDA has discussed home HIV tests since 1986. But with newer technology that makes the tests easier to use, more accurate and with quicker results, the FDA agreed to consider OraSure's proposal.
Last week, the Centers for Disease Control and Prevention recommended that all Americans between the ages of 13 and 64 be routinely tested for HIV, the virus that causes AIDS. Previously, the CDC had recommended routine testing only in high-risk groups.
OraSure has been selling a rapid HIV test for clinical settings since 2002. OraSure's test can detect with more than 99 percent accuracy whether a person has HIV-1 or HIV-2, using a swab to collect cells in saliva in the mouth. The swab is placed in a vial of testing fluid, and 20 minutes later the result is known. The test can also screen HIV in blood.
