FDA Clears First Rapid Diagnostic Test for Ebola

Regulatory NewsRegulatory News | 10 October 2019 |  By 

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on Thursday allowed the marketing of the first rapid diagnostic test for the Ebola virus that has not been authorized via the agency’s Emergency Use Authorization (EUA) pathway.

OraSure Technologies’ OraQuick Ebola Rapid Antigen Test, which provides a rapid, presumptive diagnosis that must be confirmed, gained market entry via CDRH's De Novo review pathway less than five months after its request for classification was submitted (FDA's De Novo performance goal review time is 150 days). The test was also granted a Breakthrough device designation.

“This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving,” acting FDA Commissioner Ned Sharpless said. 

The Ebola outbreaks in the Democratic Republic of Congo and in West Africa dating back to 2014 have killed more than 11,000.

Previously, FDA worked quickly with the CDC and test developers to make diagnostic tests, including the OraQuick Ebola Test, available via the EUA pathway to address this public health emergency.

“For the OraQuick Ebola Test 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 studies.
Based on these data, the FDA determined that general and special controls were necessary to provide a reasonable assurance of the safety and effectiveness of the OraQuick Ebola Test when intended to identify antigens associated with Ebola virus in blood from symptomatic patients and oral fluid of cadavers,” FDA said.

And the agency notes that the test is not intended for general Ebola infection screening (e.g., airport screening) or the testing of individuals at risk of exposure without observable signs of infection.



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