FDA Clears Rapid Diagnostic Test for Ebola
The FDA granted OraSure Technologies marketing clearance for its OraQuick rapid test for Ebola in human blood. The test provides a presumptive diagnosis that must be confirmed by further testing.
The clearance was the first for a rapid Ebola test via through the De Novo review pathway. OraQuick also received a breakthrough device designation.
The test is intended for use in patients suspected of and with signs or symptoms consistent with Ebola infection. It is not intended to be used for general Ebola infection screening or testing of individuals at risk of exposure without observable signs of infection, the agency said.