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FDA Approves New Roche West Nile Virus Blood Screening Test
Date:9/3/2007

West Nile Virus by nucleic acid amplification tests has markedly reduced the risk of transfusion transmission.

About West Nile Virus

Most people infected with West Nile Virus never show signs of illness or experience several days of flu-like symptoms, but others, especially those with compromised immune systems, can suffer serious and in some cases life threatening reactions. According to the US Centers for Disease Control, in 2002, transfusion-associated transmission (TAT) of West Nile virus (WNV) infection acquired through blood transfusion marked the emergence of a new threat to the U.S. blood supply. Although mosquito-borne transmission remains the predominant mode of WNV transmission, identification of TAT underscored the need for WNV screening of donated blood. In June 2003, blood-collection agencies implemented investigational WNV nucleic acid-amplification tests (NATs) to screen all blood donations and identify potentially infectious donations for quarantine and retrieval. This screening was performed on approximately 6 million units during June--December 2003, resulting in the removal of at least 818 viremic blood donations from the blood supply in 2003 alone.

About Roche Diagnostics Blood Screening

Roche Diagnostics is the leading provider of PCR-based nucleic acid tests for the international blood bank market. Nucleic acid-based tests enable more highly sensitive detection of active HIV, Hepatitis C, and Hepatitis B infections than conventional antibody or antigen assays. Roche assays have been used by the Japanese Red Cross since 1999 to screen Japan's entire blood supply. In 2006, Roche launched the automated cobas s 201 system and the 5-parameter multiplex cobas TaqScreen MPX Test in Europe for the most comprehensive single-assay detection of HIV-1 groups M & O, HIV-2, and Hepatitis B and C in donated blood and plasma. The West Nile Virus test is the first test available on the automated cobas s 201 system in the US, where the
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SOURCE Roche Diagnostics
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