Gen-Probe seeks approval from FDA to use Procleix Tigris system to screen for West Nile Virus

By Lisa Kerner

Erie, Pa., April 20 - Gen-Probe Inc. submitted a 510(k) application to the Food and Drug Administration for use of the Procleix Tigris system to screen donated human blood, tissue and organs for the mosquito-borne West Nile virus with the Procleix West Nile virus assay.

The Procleix West Nile virus assay was approved by the FDA in December for use on the enhanced semi-automated Procleix system (eSAS), according to a company news release.

The Tigris system has been used to screen about 3.6 million donations for West Nile virus is select U.S. blood centers under Investigational New Drug applications. Because the system can process 1,000 blood samples in about 14 hours, it allows for testing in smaller pool sizes and individual donor testing.

Gen-Probe said its Tigris system is approved in countries outside the United States to screen donated human blood, tissue and organs with the Procleix Ultrio assay.

San Diego-based Gen-Probe develops, manufactures and markets nucleic acid tests to diagnose diseases and screen donated human blood.

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