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U.S. News

Chembio Diagnostics Receives FDA "Approvable" Letter for Rapid HIV Tests

April 20, 2006

FDA has issued an "approvable" letter to Medford, N.Y.-based Chembio Diagnostics for its rapid HIV tests SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK as long as certain conditions are met, the company announced Wednesday, the United Press International reports (United Press International, 4/19). The products detect HIV-1 and HIV-2 antibodies and give results in about 15 minutes. According to the letter, the agency must review the package inserts for each test before granting final approval, Long Island Newsday reports. If the products are approved, Chembio will be allowed to sell the tests to clinical laboratories and hospitals nationwide (Kerr, Long Island Newsday, 4/19). Javan Esfandiari, Chembio's vice president of research and development, said, "Rapid tests allow greater access to testing, which results in more people being diagnosed earlier, when treatment is most effective" (Chembio release, 4/19).

Back to other news for April 20, 2006


Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2006 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.



  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
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