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West Nile virus (WNV) is a mosquito-borne virus that can cause mild, flu-like symptoms as well as severe neurological disease. The first confirmed U.S. death resulting from WNV transmission through donated blood was reported in 2002. In the fall of that year, the FDA challenged industry to develop a test for the direct detection of WNV in donated blood. Gen-Probe met this challenge in June of 2003, and since then U.S. blood centers have used the PROCLEIX WNV assay to screen tens of millions of units of donated blood, intercepting more than 1,500 infected donations. The PROCLEIX WNV Assay was
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