Ebola diagnostic receives emergency use authorization

The Food and Drug Administration has allowed the Xpert Ebola test from Cepheid to be used through an emergency use authorization, the company announced on Tuesday.

The test is specified for the Zaire strain of Ebola virus disease (EVD) and utilizes molecular diagnostics technology that keeps samples in the cartridge itself to limit risks of contamination and spread. The authorization will last until the outbreak is declared to be finished or if the test shows to be in need of further development.

"With support from the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation (provided via the National Philanthropic Trust Fund for Global Health and Development), Cepheid was able to leverage its extensive development experience to expedite delivery from the initial prototype to an emergency-use-only product in just 90 days," Dr. David Persing, Cepheid's chief medical and technology officer, said. "We expect that this technology will help to expedite the evaluation of suspected cases and to enable more effective field surveillance activities already underway in endemic areas."

EVD was originally discovered in 1976 in what is now called the Democratic Republic of the Congo near the Ebola River; since then, there have been sporadic outbreaks in different regions across Africa. The current outbreak is the largest since the virus' discovery.

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FDA Office of Medical Products and Tobacco

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