(FDA) The FDA has approved the first blood test created to screen blood donors for the West Nile Virus. The Procleix WNV Assay, developed by Gen-Probe Inc., and marketed by Chiron Corporation, helps protect patients who receive blood and other such products against West Nile infection.
To date, there have been 30 documented cases of people who most likely acquired WNV from a blood transfusion, including nine who 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," 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."
West Nile Virus is typically transmitted to humans by mosquito bites. It was first detected in the United States 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. It is estimated that between 1 and 2 million people have been infected with WNV.
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.
Bankruptcy – Business
Bankruptcy – Personal
Criminal Law – Appellate
Criminal Law – Federal
Criminal Law – State Felony & Misdemeanor
Drunk Driving Defense
Dumb or Weird Laws
GM Ignition Switch
Stryker Hip Replacement
Intellectual Property Law
Labor & Employment Law
Landlord Tenant Law
Personal Injury – Defendant
Personal Injury – Plaintiff
Social Security Disability
Weird Law Friday
Trending Searches#TBT #ThrowbackThursday constitutional law Criminal Law - State Felony & Misdemeanor dangerous or defective products divorce DUI dumb laws estate planning Events that Changed History Family Law FAQ first-amendment product-recall products liability random laws recall safety recall strange laws weird laws