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FDA Allows Marketing Of Rapid Diagnostic Test For Detecting Ebola Virus

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The U.S. Food and Drug Administration has allowed marketing of a rapid diagnostic test to detect Ebola virus antigens in human blood.

The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease. The test provides a rapid, presumptive diagnosis that must be confirmed.

"Today's marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the U.S. Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo (DRC)," said Acting FDA Commissioner Ned Sharpless.

The current outbreak in the Congo has already killed thousands and the outbreaks in West Africa that began in 2014 tragically killed more than 11,000. Quickly diagnosing the disease could help stopping these outbreaks.

EVD, which is caused by the Ebola virus, is a severe, often fatal disease in humans that can spread through direct contact with blood or body fluids or objects contaminated with body fluids, as well as from the bodies of those who have died from the virus.

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