FDA Approves First Fully Automated Test to Screen for West Nile Virus in Blood and Tissue Donors

The U.S. Food and Drug Administration (FDA) today announced the approval of a license supplement for the first fully automated West Nile Virus (WNV) nucleic acid test for donor screening. The Procleix WNV Assay on the Procleix TIGRIS system is licensed to detect the virus’ genetic material in plasma specimens from individual donors of blood, tissue and organs, and other living donors. It is not intended for use on cord blood specimens or as an aid in the diagnosis of WNV infection.

The Procleix WNV Assay on the Procleix TIGRIS system can be used for testing individual donor samples or for testing pooled samples from up to 16 individual donations of whole blood and blood components. This assay system provides flexibility that allows implementing testing of individual blood donor samples more extensively during periods of high WNV activity.

The Procleix Tigris system is fully automated and is capable of performing certain steps that are generally performed by technologists when using semi-automated systems. The difference between this assay system and the previously approved Procleix semi-automated platform is the degree of automation.

“The capability of full automation can reduce the potential for human error while accelerating donor screening and enhancing the safety of blood and tissues,” said Jesse Goodman, M.D., director of FDA’s Center for Biologics Evaluation and Research. ”This is the latest step forward in what has been a very successful industry-government effort to keep blood safe from the emerging threat of West Nile virus"

WNV is typically spread by infected mosquitoes. However, transmission does occur, although much less commonly, through blood transfusion or organ transplantation. While most infected individuals have mild disease and recover spontaneously, infection can be serious or even fatal. WNV was first detected in the United States in 1999, and has recurred each year ever since then, becoming endemic in the country. It is estimated that between one and three million people have been infected with WNV.

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