bioMérieux's FilmArray Ebola test gains FDA emergency use authorisation

On Monday, bioMérieux's BioFire Defense unit announced that its FilmArray Ebola test, called the BioThreat-E test, received emergency use authorisation from the FDA for use in hospitals and commercial laboratories, along with laboratories designated by the US Department of Defense. Randy Rasmussen, CEO of BioFire Diagnostics, noted that as FilmArray is routinely used in 300 hospitals, "authorisation of emergency use...by [the] FDA instantly creates an extensive Ebola testing network in the US."

The test, which detects the Ebola virus in body fluids, runs on the company's polymerase chain reaction molecular diagnostic BioFire FilmArray system and delivers results in one hour, bioMérieux said. BioFire Defense vice president of sales and marketing Matt Scullion noted that "we have managed to come up with a system that has automated all of the traditional steps that you'd go through to set up a test like this," adding that current tests can take 24 hours to 48 hours to deliver results.

According to bioMérieux, the BioThreat-E test is available to high and moderate complexity clinical laboratories in the US as long as "circumstances exist justifying the authorisation of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus." The company, which had requested FDA emergency US authorisation on October 18, added that it is prepared to work with local authorities so the test is available in all countries where needed for clinical testing.

FDA spokeswoman Sharon Yao remarked "obviously, having more tests authorised for use during this outbreak is a benefit," adding "hospitals can now test human specimens for Ebola in their facilities and obtain a determination in under two hours."

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