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US FDA approves OraSure's diagnostic test for Ebola virus

The U.S. Food and Drug Administration granted marketing authorization to OraSure Technologies Inc.'s test for the detection of Ebola virus antigens.

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The regulatory agency approved the OraQuick Ebola Rapid Antigen test as the first rapid diagnostic test for Ebola virus disease, or EVD. The test provides a presumptive diagnostic and the results need to be confirmed, the FDA noted in its Oct. 10 press release.

Additionally, the OraQuick test is not to be used for general Ebola infection screening or testing of individuals at risk of exposure without observable signs of infection. The test can also be used to identify the virus in deceased individuals with EVD as the suspected cause of death.

EVD is often fatal and spreads through direct contact with blood or body fluids or objects contaminated with the virus.

Members of the U.S. Department of Health and Human Services termed the ongoing Ebola outbreak in the Democratic Republic of Congo, which has lasted more than a year, as a national security concern. It is the second-largest Ebola outbreak in history with a death toll of more than 1,800 patients.

The FDA has allowed the use of a number of diagnostic tests for EVD under its emergency use authorization pathway, which allows the regulatory body to temporarily authorize the use of unapproved medical products to address a public health emergency.

The U.S. regulator's approval is based on data from multiple clinical trials using blood samples and oral fluids from the 2014 West African outbreak.