Gen-Probe's West Nile virus test approved by FDA

New York, Dec. 1 - Gen-Probe Inc. said that it received marketing approval from the Food and Drug Administration for its Procleix West Nile virus assay to screen donated human blood on the Procleix enhanced semi-automated instrument system.

"FDA approval of our West Nile virus assay represents another significant milestone in our efforts to help safeguard the U.S. blood supply with our innovative nucleic acid testing technologies," said Henry L. Nordhoff, chairman, president and chief executive officer of Gen-Probe, in a news release.

"The entire development program for this highly accurate assay, which began only three years ago, has been a tremendous success story for Gen-Probe, and once again demonstrates our ability to rapidly commercialize molecular diagnostic tests that improve human health."

Since June 2003, U.S. blood centers have already used the Procleix West Nile virus assay to screen more than 29 million units of donated blood under an investigational new drug application. The testing intercepted approximately 1,500 West Nile-infected units, thereby preventing transfusion of contaminated blood into as many as 4,500 people, the San-Diego-based maker of nucleic acid tests said.

Based on the early approval of the West Nile virus assay on the enhanced semi-automated instrument system and recent discussions with the FDA and customers, Gen-Probe said it has decided to accelerate the necessary regulatory filings for use of the West Nile virus assay on its fully automated, high-throughput Tigris system.

Gen-Probe added that it intends to file for this clearance in the first part of 2006.

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