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BioMerieux working to get FDA approval for Ebola screening test
October 20, 2014 / 8:32 PM / in 3 years

BioMerieux working to get FDA approval for Ebola screening test

Oct 20 (Reuters) - BioMerieux SA is working with U.S. health regulators to determine if its test to screen for bio threats could be used to detect the Ebola virus, spokeswoman Suzanne Jones said.

The FilmArray system was originally developed for pandemic surveillance and to screen for bio threats - agents like bacteria and viruses that could be used in biological warfare.

Since the system was solely developed for environmental surveillance, it is necessary for BioMerieux to show the U.S. Food and Drug Administration evidence that the test could be used clinically, Jones said in an emailed statement.

The statement follows media reports on how health officials in Dallas were not able to use the test which screens the disease under an hour, because FDA guidelines prohibited them from using it on patients. (bit.ly/1t5faDG) (Reporting by Amrutha Penumudi in Bangalore; Editing by Savio D'Souza)

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