The FDA has approved the Procleix WNV Assay, developed by Gen-Probe Inc., and marketed by Chiron Corporation. According to the FDA’s press release:
“This approval is the result of a tremendous cooperative effort among 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.”
In 2002, it was discovered that WNV could be transmitted in blood and an urgent effort to develop a blood test began. With support from FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, manufacturers developed investigational WNV tests that were rapidly put in place both to evaluate their effectiveness and as an interim measure to protect the blood supply. Blood banks across the United States participated in these efforts, resulting in the detection and removal of approximately 1,600 infected donations, safeguarding the blood supply and providing the needed data for today’s approval.