West Nile Virus Screening Test Gains FDA Approval
New kit will enable donated blood, organs, cells and tissue to be tested for the disease
MONDAY, Dec. 5 (HealthDay News) -- The U.S. Food and Drug Administration announced that it has approved the first West Nile virus (WNV) blood test. The Procleix WNV Assay, which was developed by Gen-Probe Inc. and is marketed by Chiron Corp., will be used to test donated blood, organs, cells and tissue for the virus. There have been 30 cases so far of WNV infection via blood transfusion, including nine cases that were fatal.
Efforts to develop a WNV blood test began in 2002 when it was discovered that the disease could be transmitted in blood. The development of a test was supported by the FDA, the U.S. Centers for Disease Control and Prevention and the National Institutes of Health. As tests were developed they were rapidly deployed, in collaboration with blood banks across the United States, to establish effectiveness, a process which resulted in the removal of 1,600 infected donations and provided the necessary data for the approval of the Procleix test.
"This approval is the result of a tremendous cooperative effort among FDA, other public health agencies, the test kit manufacturers and the blood industry," said Jesse Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research, in a statement.
Since 2002, consecutive annual outbreaks of the mosquito-borne disease have caused almost 20,000 human cases leading to at least 762 deaths.