FDA Okays Gene Test to Screen Donor Blood for West Nile

ROCKVILLE, Md., March 5 -- The FDA has licensed an automated nucleic acid test, to screen donor blood for West Nile virus.

The Procleix WNV Assay, which uses the Procleix Tigris system, was licensed to detect West Nile virus RNA in plasma specimens from donors of blood, tissue, and organs. It is not intended for screening cord blood specimens or for diagnosis of West Nile infection.

The FDA said the Tigris system could be used for testing of both individual samples and for testing pooled samples from up to 16 individual donors.

According to the FDA, the fully automated system is "capable of performing certain steps that are generally performed by technologists when using semi-automated systems."

Jesse Goodman, M.D., director of FDA's Center for Biologics Evaluation and Research, said the Procleix test was the latest step in an "industry-government effort to keep blood safe from the emerging threat of West Nile virus." The virus is typically spread by infected mosquitoes, but transmission also occurs, though much less commonly, through blood transfusion or organ transplantation.

The Procleix WNV Assay on the Procleix Tigris system is manufactured by Gen-Probe Inc. and is marketed by Chiron.