The FDA approved Roche’s BLA related to its test for direct detection of West Nile virus in donated human blood and plasma. West Nile can 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 company.
The test is designed to run on the cobas 201 system, Roche’s flexible, modular instrument platform that automates each step of the real-time PCR blood screening process. The test uses Roche’s PCR technology to detect the genetic material of the West Nile virus directly in blood.