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BioFire Ebola Test Receives WHO Emergency Use Assessment and Listing

NEW YORK (GenomeWeb) – BioMérieux subsidiary BioFire Defense has received Emergency Use Assessment and Listing (EUAL) from the World Health Organization for its FilmArray BioThreat-E test for the Ebola virus, the company announced today.

With EUAL, the assay is now eligible for WHO procurement.

"This authorization fits our mission to help improve public health through a facilitated access to quality diagnostics," Kirk Ririe, CEO of BioFire Defense, said in a statement.

"The rapid turnaround time, reliability, and ease-of-use of FilmArray will certainly be a great help to healthcare professionals for the diagnosis of Ebola in this unprecedented outbreak," he added.

The WHO had previously assessed new in vitro diagnostic technologies annually, but instituted the EUAL emergency mechanism for Ebola in response to the outbreak in West and Central Africa. There are currently six Ebola tests accepted for procurement through the EUAL Procedure for IVDs, including assays from Cepheid and Altona Diagnostics.

Salt Lake City-based BioFire Defense received Emergency Use Authorization from the US Food and Drug Administration to use the commercially available Film Array BioThreat-E test on patients during the height of the outbreak last year. It's FilmArray NGDS BT-E Assay, which also detects Ebola, received EUA a few weeks later for use in US Department of Defense laboratories.

The BioFire tests are among 10 assays to get EUA since an emergency was declared.

The assay was also the subject of a recent head-to-head comparison with other PCR-based tests, and a 2.0 version of the Film Array platform was FDA-approved and CE-IVD-marked earlier this year.