FDA Approves New HIV Blood Test That Screens Blood, Tissue Donations For Less Common Strains

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Liver Disease / Hepatitis
Article Date: 06 Jan 2009 - 3:00 PDT

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FDA last week approved a new HIV test manufactured by a Roche subsidiary that screens for two less common forms of the virus in the U.S., in addition to the most common forms of HIV and hepatitis, the AP/Miami Herald reports. The test is designed to screen blood and tissue samples from donors for infectious diseases. According to FDA, the TaqScreen MPX Test is the first to be able to detect HIV-2 and HIV-1 Group O strains of the virus at the same time (AP/Miami Herald, 12/30/08). Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, said, "With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients" (Dooren, Dow Jones/Wall Street Journal, 12/30/08). According to the AP/Herald, the two HIV strains are most commonly found in Africa but have recently been detected by FDA in the U.S. (AP/Miami Herald, 12/30/08).

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