FDA approves rapid Ebola test for hospital use

Food and Drug Administration Logo
Food and Drug Administration Logo

In response to the Ebola scare, the Food and Drug Administration (FDA) rushed approval of a rapid-result Ebola test for hospital use on Saturday.

The FDA issued an Emergency Use Authorization for the FilmArray Biothreat-E.1 test manufactured by Biofire Defense LLC. The test can confirm or rule out Ebola in patients showing symptoms in approximately an hour. It also can detect respiratory, gastrointestinal and blood-borne illnesses. 

Up until now, Ebola testing could only be done at the CDC or certain state labs. Patients presenting to emergency departments with possible exposure to Ebola and symptoms were quarantined and not treated for hours at a time while awaiting test results. This waiting period could be detrimental to the health of the patient if there was something else going on such as a stroke, myocardial infarction or sepsis.

Due to the current fear of Ebola, some patients even have been isolated simply due to their travel history and possible exposure to the disease. 

BioFire Defense has made its Biofire analyzer available to 300 hospitals so far, and another 800 test kits are ready to ship.

Organizations in this Story

University of Pennsylvania Medical Center

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