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Medical Devices / Submissions and Approvals

OraSure Ebola Test Gets FDA Emergency Use Authorization

Aug. 5, 2015
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OraSure Technologies received emergency use authorization from the FDA for its OraQuick Ebola rapid antigen test to detect the Ebola Zaire virus detected in the West Africa outbreak of 2014.

In announcing its authorization, the FDA said the test may also detect antigens for the Sudan and Bundibugyo Ebola viruses, but does not distinguish among the three.

OraQuick is to be used when a rapid virus test is more appropriate that the use of an authorized Ebola virus nucleic acid test which has been demonstrated to be more sensitive in detecting the Zaire virus and is not intended for general screenings such as at airports or tracing of individuals without symptoms of the disease.

OraSure said the test has not been cleared by the FDA but that it did receive the emergency authorization. The Bethlehem, Pa., company develops, manufactures and distributes point-of-care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. — John Bechtel