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Enhanced Screening System for West Nile Virus Receives FDA Approval

The U.S. Food and Drug Administration (FDA) recently approved a license supplement
for the first fully automated nucleic acid test for donor screening of the West Nile virus
(WNV). On March 2, 2007, the FDA announced that the Procleix WNV Assay on the
Procleix TIGRIS system was licensed to detect the virus’ genetic material in plasma
specimens from individual blood, tissue and organ donors.

The new screening system can be used to test individual donor samples or pooled
samples from up to 16 individual donations of whole blood and blood components. The
system is not intended for use on cord blood specimens or as an aid in the diagnosis of
WNV infection.

The new system is manufactured by Gen-Probe of San Diego and marketed by Chiron
Corporation, which is headquartered in Emeryville, CA. Chiron is the blood screening
business of Novartis Vaccines and Diagnostics, a division of Novartis AG.  

According to the FDA, the primary advantage of the Procleix Tigris system is its speed
and reliability. “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, MD, director of the 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.”
Source: FDA news release dated March 2, 2007