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FDA Grants Emergency Use Authorisation for Cepheid Ebola Diagnostic Test.

MANews-(C)2009-2015

- US-based diagnostic test developer Cepheid (NASDAQ: CPHD) has received Emergency Use Authorization from the US Food and Drug Administration for Xpert Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours.

The test runs on the Cepheid GeneXpert Systems molecular diagnostic platform.

Ebola was first discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo. Since then, outbreaks have appeared sporadically in Africa.

The 2014 Ebola epidemic is the largest in history, affecting multiple countries in West Africa.

In the United States four cases have been reported: two imported cases that included one death, and two locally acquired cases in healthcare workers.

On August 5, 2014 the US secretary of Health and Human Services declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus.

Cepheid's Xpert Ebola has not been FDA cleared or approved, but will remain available in the US as an EUA product as long as the declared emergency remains in effect or it ceases to be authorised by FDA.

Xpert Ebola has been authorised by FDA under an Emergency Use Authorization for use by CLIA moderate and high complexity laboratories or similarly qualified non-US laboratories.

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Publication:M & A Navigator
Date:Mar 25, 2015
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