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Associated Press

OraSure finishes FDA submission for HIV test


Associated Press - January 3, 2012

OraSure completes FDA submission for potential over-the-counter test for HIV BETHLEHEM, Pa. (AP) -- OraSure Technologies Inc. said Tuesday it has completed its submission of a potential over-the-counter HIV test to the Food and Drug Administration for approval.

The Bethlehem, Pa., company, which makes diagnostic kits to detect HIV and drug use, said it submitted the third and final phase of clinical testing on its OraQuick test to regulators.

That phase involved testing of 5,800 people around the country. OraSure said the testing led to the identification of more than 100 previously undiagnosed individuals with HIV. The company said there are about 1.2 million people in the United States with HIV, the virus that causes AIDS, and about 240,000 are unaware they have the virus.

The company will provide a toll-free call center that offers customer support and referral services around the clock.

OraSure started submitting data to the FDA in last year's third quarter. The company also makes the OraQuick Advance HIV test, which is used in hospitals and doctor's offices.


Copyright © 2012 -Associated Press, Publisher. All rights reserved to Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.

Information in this article was accurate in January 3, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.