Blood, Organs, and Tissues Screened for West Nile Virus

This level of productivity facilitates individual donor testing, which increases screening sensitivity and blood safety. Blood testing sites typically screen for WNV using pooled samples. When predetermined WNV prevalence triggers are met in their geographic areas, they switch to individual donor testing.

Gen-Probe Incorporated (San Diego, CA, USA) announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Procleix Tigris System. FDA approval of our unique Procleix Tigris System for west Nile virus testing is a major milestone for Gen-Probe and a significant advance for blood centers nationwide, said Henry L. Nordhoff, chairman, president, and CEO of Gen-Probe. The Procleix Tigris System is the only fully automated, high-throughput testing platform for molecular diagnostics, enabling blood centers to maximize the efficiency of blood screening. At the same time, it employs state-of-the-art process controls to minimize hands-on intervention and the potential for human error.

Blood centers have used the Procleix Tigris System to screen millions of units of donated blood for WNV under an investigational new drug (IND) application since the summer of 2004.

WNV is a mosquito-borne virus that causes disease ranging from mild, flu-like symptoms to severe encephalitis. The first confirmed death in the United States resulting from transmission through donated blood was reported in 2002. In the fall of 2002, the FDA challenged industry to develop a test for the direct detection of WNV in donated blood by the summer of 2003. Gen-Probe and its partner Chiron, a Novartis business unit, developed the Procleix WNV Assay and began distributing it under an IND. WNV has continued to be a significant public health threat since that time. According to the U.S. Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) more than 4,200 human cases of WNV infection occurred in 2006, and nearly 350 units of WNV-infected blood were intercepted.

The Procleix Tigris system is approved for commercial blood screening use with the Procleix Ultrio assay in many countries outside the United States. The Procleix Ultrio assay simultaneously detects HIV-1, hepatitis C, and hepatitis B.

In the clinical diagnostics arena, the Tigris system received clearance from the FDA in 2003 for use with the Aptima Combo 2 assay, to detect Chlamydia trachomatis and Neisseria gonorrhoeae.

Gen-Probe Incorporated develops, manufactures, and markets rapid, accurate, and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 24 years of NAT expertise, and received the 2004 National Medal of Technology (the highest honor in the United States) for technologic innovation, for developing NAT assays for blood screening.


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