FDAnews Device Daily Bulletin

FDA APPROVES TEST TO SCREEN FOR WEST NILE VIRUS IN TISSUE DONORS

Dec. 5, 2005
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The FDA has approved the first West Nile Virus (WNV) blood test to screen donors of blood, organs, cells and tissues, the agency announced.

The Procleix WNV Assay, developed by Gen-Probe and marketed by Chiron Corporation, detects viral genetic material (ribonucleic acid or RNA). The new test will help protect patients who receive blood and other such products against West Nile infection, the FDA said. To date, there have been 30 documented cases of people who most likely acquired WNV from a blood transfusion, including nine who died.

The virus is typically transmitted to humans by mosquito bites, and was first detected in the U.S. in 1999. In 2002, it was discovered that WNV could be transmitted in blood and an urgent effort to develop a blood test began, the agency noted.

"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, director of the FDA's Center for Biologics Evaluation and Research. "To develop an investigational test to screen blood, tissue and organ donors, and to get this test in blood banks throughout the country, and then licensed this quickly is a remarkable achievement for public health and patient safety."