FDA approves West Nile test to screen blood

Dec 2, 2005 (CIDRAP News) – A test to screen blood and organ donors for West Nile virus (WNV) has won approval by the Food and Drug Administration (FDA) after 2 years of trial use.

The FDA yesterday announced approval of the Procleix West Nile virus assay, developed by Gen-Probe Inc., San Diego, and marketed by Chiron Corp., Emeryville, Calif. The test detects West Nile RNA in blood.

The test has been used to screen more than 29 million units of donated blood since June 2003 and has detected the virus in more than 1,500 cases, preventing transfusion of contaminated blood into as many as 4,500 people, Gen-Probe officials said in a news release.

The test is intended to help protect recipients of donated blood and organs from the virus. The FDA said there have been 30 cases in which people probably acquired WNV from a blood transfusion, and nine of the patients died.

"This approval is the result of a tremendous cooperative effort among FDA, other public health agencies, the test kit manufacturers and the blood industry," Jesse Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, said in a news release.

"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," Goodman added.

Another blood test is available to help doctors diagnose WNV, but it must be used in tandem with other laboratory tests, according to a Reuters report published yesterday. Procleix is the first approved test that stands alone, making it suitable for use by blood banks, the story said.

Another WNV blood test, developed by Roche Molecular Systems, Inc., is still being used experimentally, Reuters reported. An FDA official said the agency is allowing Roche to use the test on a trial basis until it has enough data to apply for approval, the story said.

Efforts to develop a WNV blood test began in 2002 when it was discovered that the virus could be transmitted in blood, the FDA said. With help from the FDA and other federal health agencies, biotechnology firms developed investigational tests that were quickly adopted on a trial basis. A total of about 1,600 infected donations were detected by the investigational tests, the FDA said.

Close to 20,000 cases of WNV illness, with 762 deaths, have occurred in the United States since the virus first arrived in 1999, the FDA said.

See also:

FDA news release about WNV blood test
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108523.htm

Apr 8, 2004, CIDRAP News story "Six West Nile cases in 2003 linked to donated blood"

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