OraSure Finishes FDA Submission for Over-the-Counter HIV Test
January 4, 2012
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.
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.
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