FDA approves first test to screen WNV in organ, tissue, cell, blood donors; will be marketed by Chiron

Transplant News,  Dec 15, 2005  

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The Chiron Corporation, Emeryville, CA, announced the US Food and Drug Administration (FDA) has approved the Procleix West Nile Virus (WNV) Assay to screen organ, tissue, cell and blood donors. The new test, which was developed in collaboration with Gen-Probe, Inc., San Diego, CA, detects viral genetic materials which will help protect patients who are transplanted or transfused against WNV.

The assay has been used to screen more than 29 million units of blood on an investigational -use-only basis since June of 2003 and intercepted more than 1,500 WNV-positive donations, Chiron says.

"This approval is the result of a tremendous cooperative effort among the FDA, other public health agencies, the test kit manufacturers and the blood industry," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "To develop an investigational test to screen blood, tissue and organ donors, and to get this test in blood banks throughout the country, and then licensed this quickly is a remarkable achievement for public health and patient safety."

WNV is typically transmitted to humans by mosquito bites. It was first detected in the US in 1999, and has reoccurred each year for seven consecutive years, causing close to 20,000 human cases of disease and at least 762 deaths since 2002. To date, there has been 30 documented cases of people who most likely acquired WNV from a blood transfusion, including nine who died. It is estimated between 1 and 2 million people have been infected with WNV.

Contact: Julie Zawisza, FDA - (301) 827-6242; Chiron - (410-923-6500), Web site: www.chiron.com

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