OraSure Finishes FDA Submission for HIV Test

Bethlehem, Pa.-based OraSure Technologies said Tuesday it has completed a submission seeking Food and Drug Administration approval of its over-the-counter HIV test.

The company, which makes the OraQuick Advance HIV test used in hospitals and doctor’s offices, began submitting data for the new approval in the third quarter of 2011.

It now has sent FDA the third and final phase of clinical trial results, which involved 5,800 US residents and led to the identification of more than 100 HIV-positive individuals who had not been diagnosed previously.

OraSure said it will provide an around-the-clock, toll-free call center offering customer support and referral services.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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