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FDA NEWS RELEASE

For Immediate Release: Aug. 25, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries:
888-INFO-FDA

FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas

The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas.

The EUA allows the U.S. Department of Defense to distribute the H1N1 test to its qualified laboratories that have the required equipment and trained personnel to perform the test and interpret its results. An EUA authorizes the use of unapproved medical products or unapproved uses of approved medical products during a declared public health emergency.

“The FDA worked quickly with the Defense Department to authorize the use of this test to better protect our troops. The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

The U.S. Centers for Disease Control and Prevention (CDC) developed the test, which is called the CDC swH1N1 (swine) Influenza Real-Time RT-PCR.

Under this new EUA, the Defense Department’s Joint Biological Agent Identification and Diagnostic System (JBAIDS) can be used to run the CDC’s test. The FDA previously cleared other assays for use on the JBAIDS beginning in 2005.

For more information:

Department of Defense Aug. 24, 2009, News Release on EUA

FDA Authorizes Emergency use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans, April 27, 2009

FDA’s Web site on 2009 H1N1 Influenza Virus

 

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