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"We are pleased to offer US blood banks a new choice for both maximizingblood safety and optimizing efficiency," said Daniel O'Day, Head of RocheMolecular Diagnostics, the business area of Roche Diagnostics which developedthe test. "The Roche test, run under an investigational new drug applicationby 14 clinical trial sites testing blood from a network of more than a 100donation centers, helps blood banks streamline workflow and improve testresults accuracy with reduced hands-on time, ready-to-use reagents, and fullautomation of each step."
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The test is designed to run on the cobas s 201 system, Roche's flexible,modular instrument platform which automates each step of the real-time PCRblood screening process. The test uses Roche's highly sensitive polymerasechain reaction technology (PCR), the world's leading nucleic acidamplification technology, to detect the genetic material of the West Nilevirus directly in blood. The United States Centers for Disease Control (CDC)has stated that screening donated blood for West Nile Virus by nucleic acidamplification 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 orexperience several days of flu-like symptoms, but others, especially thosewith compromised immune systems, can suffer serious and in some cases lifethreatening reactions. According to the US Centers for Disease Control, in2002, transfusion-associated transmission (TAT) of West Nile virus (WNV)infection acquired through blood transfusion marked the emergence of a newthreat to the U.S. blood supply. Although mosquito-borne transmission remainsthe predominant mode of WNV transmission, identification of TAT underscoredthe need for WNV screening of donated blood. In June 2003, blood-collectionagencies implemented investigational WNV nucleic acid-amplification tests(NATs) to screen all blood donations and identify potentially infectiousdonations for quarantine and retrieval. This screening was performed onapproximately 6 million units during June--December 2003, resulting in theremoval of at least 818 viremic blood donations from the blood supply in 2003alone.
About Roche Diagnostics Blood Screening
Roche Diagnostics is the leading provider of PCR-based nucleic acid testsfor the international blood bank market. Nucleic acid-based tests enable morehighly sensitive detection of active HIV, Hepatitis C, and Hepatitis Binfections than conventional antibody or antigen assays. Roche assays havebeen used by the Japanese Red Cross since 1999 to screen Japan's entire bloodsupply. In 2006, Roche launched the automated cobas s 201 system and the5-parameter multiplex cobas TaqScreen MPX Test in Europe for the mostcomprehensive single-assay detection of HIV-1 groups M & O, HIV-2, andHepatitis B and C in donated blood and plasma. The West Nile Virus test is thefirst test available on the automated cobas s 201 system in the US, where themultiplex HIV, HCV, and HBV test is currently under FDA review.
About Roche and the Roche Diagnostics Division
