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FDA Approves Bayer, Roche HIV Tests for Use on Blood Plasma, Organs

March 3, 2004

FDA has approved HIV tests made by Bayer and Roche that are able to detect the virus in blood plasma, Bloomberg News/New York Times reports (Bloomberg News/New York Times, 3/3). Blood plasma is used in many protein-based therapeutic products, including those used to treat shock, hemophilia, immunodeficiency syndromes, burns and other conditions (Roche release, 3/2). The Roche test, which is already in use in the United States and other countries for screening whole blood donations, uses patented technology to detect genetic HIV-1 material during the early stages of infection. Traditional HIV-1 testing detects antibodies associated with HIV-1 that take longer to appear in the body after infection. In addition to blood plasma, the new test will be used to test organs for use in transplants (Indianapolis Star, 3/3). The Bayer test, which uses some of the technology from the Roche test, "is as sensitive as those available through commercial laboratories," Bayer said, according to the Bloomberg News/Times. FDA approval of the test will make Bayer the first plasma processor to conduct internal plasma screening, making it possible to notify HIV-positive plasma donors and prevent them from making further donations (Bloomberg News/New York Times, 3/3).

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