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OraSure Technologies Rapid Ebola Test Granted Marketing Authorization by FDA

NEW YORK – The US Food and Drug Administration has allowed marketing of a rapid lateral flow immunoassay-based test from OraSure Technologies to detect Ebola virus infection, the company announced on Thursday.

The test, which was reviewed under the de novo premarket review pathway, is the first rapid diagnostic for Ebola that the FDA has allowed to be marketed and it was also granted breakthrough device designation by the agency. 

The OraQuick Ebola Rapid Antigen Test is authorized to detect antigens of the Ebola virus in samples of whole blood from patients with suspected infection and symptoms as well as in oral fluid from recently deceased people with suspected infection, in order to help determine the safest burial methods. The test takes approximately 30 minutes, and positive results require confirmation using other tests.

The marketing authorization provides "another important tool in the effort to fight Ebola," according to acting FDA Commissioner Ned Sharpless. The disease is a US government priority, he said in a statement, and he emphasized that the US is now working with the World Health Organization to combat an Ebola outbreak in the Democratic Republic of Congo.

"The current outbreak in the DRC has already killed thousands, and the outbreaks in West Africa that began in 2014 tragically killed more than 11,000," Sharpless said, adding, "Investigational vaccines and therapeutics have shown promising results, but one of the most important tools in stopping these outbreaks is quickly diagnosing patients and supporting safe and dignified burials."

A number of tests for Ebola have been available through the Emergency Use Authorization (EUA) pathway since the 2014 outbreak, including the OraQuick test from Bethlehem, Pennsylvania-based OraSure.

For the de novo submission, the FDA reviewed data from multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak and from a variety of analytical evaluations. Additional studies further demonstrated the importance of testing only symptomatic individuals, according to the statement, so that the amount of virus is high enough to be detectable. The test is therefore not intended to be used for general Ebola screening or to test individuals at risk of exposure who do not yet have observable signs of infection.