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Cepheid Ebola Assay Granted FDA Emergency Use Authorization

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted Emergency Use Authorization to Cepheid's PCR-based assay for Ebola virus.

The test, called Xpert Ebola, runs on the firm's GeneXpert system. The company has placed more than 8,000 of these platforms globally. The new test has a dual-target design and runs in a self-contained cartridge to minimize potential contamination, the company said in a statement.

"Cepheid's Expert 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 authorized," Cepheid said.

The test is the ninth Ebola assay granted EUA since the emergency was declared in early August of last year.

Besides one rapid antigen test, the remaining eight approved assays are PCR-based. They include one RT-PCR test from the US Department of Defense, two from the US Centers for Disease Control and Prevention, two BioFire FilmArray assays, the LightMix Ebola Zaire rRT-PCR Test from Roche, and the RealStar Ebolavirus RT-PCR Kit from Altona Diagnostics.

Many other companies are also developing Ebola tests, including firms such as Becton Dickinson, BioInnovation SolutionsBiocartis, Ubiquitome, Genalyte, GNA Biosolutions, and Alere.

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