FDA Grants Emergency Use Authorization For Xpert Ebola Diagnostic Test

(RTTNews) - Cepheid (CPHD) on Tuesday said it has received Emergency Use Authorization from the U.S. Food & Drug Administration for Xpert Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours.

Xpert Ebola test was developed with a dual-target design to ensure high-accuracy and sensitivity for detecting the Ebola Zaire virus, detected in the West Africa outbreak in 2014. The test runs in Cepheid's self-contained cartridge to minimize potential contamination.

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.

Cepheid's Xpert Ebola has not been FDA cleared or approved. Xpert Ebola has been authorized by FDA under an Emergency Use Authorization for use by CLIA moderate and high complexity laboratories or similarly qualified non-U.S. laboratories.

The test will begin shipping in April 2015.