FDA clears Roche's West Nile Virus test

The US Food and Drug Administration has approved Roche Diagnostics' biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma. This virus, which can cause serious health issues, is transmitted to humans most often through mosquito bites, but can also less commonly be transmitted by transfusion of infected blood or blood products.

The test, called the cobas TaqScreen West Nile Virus Test, enables detection of the virus earlier in the infection cycle in donors who may show no symptoms of disease. According to the US Centers for Disease Control and Prevention (CDC), blood screening centers across the USA identified 340 donors whose blood tested positive for West Nile Virus in 2006 and 23 to date in 2007.

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 polymerase chain reaction blood screening process. The CDC has stated that screening donated blood for West Nile Virus by nucleic acid amplification tests has markedly reduced the risk of transfusion transmission.