The U.S. Food and Drug Administration (FDA) has authorized emergency use of two BioFire Defense diagnostic tests to detect the Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection, or who are at risk for exposure.
The BioFire Defense FilmArray Biothreat-E test is for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate complexity tests and by laboratories certified under CLIA to perform high complexity tests.
The FilmArray Biothreat-E Emergency Use Authorization (.pdf) for the test enables hospitals with laboratories that fit these characteristics to conduct a PCR test for Ebola in-house, without having to send the sample to an outside lab.
More than 300 U.S. hospitals already use FilmArray systems for multiplexed respiratory and gastrointestinal diagnostics. The hospitals will simply add the BioThreat-E assay kits to test for the Ebola Zaire virus on those machines.
Besides the commercial test, the FDA gave emergency authorization (.pdf) for BioFire’s FilmArray NGDS BT-E for laboratories designated by the Department of Defense (DoD).
“We believe that a fast, easy-to-use and accurate Ebola test will help in the fight against this horrible virus,” said Kirk Ririe, chief executive officer of BioFire Defense.
In August 2014, the FDA also approved emergency use for the DoD developed EZ1 rRT-PCR Assay for several validated platforms, including BioFire Defense’s Joint Biological Agent Identification and Diagnostic System (JBAIDS).
In Spring 2014, BioFire Defense was awarded the Next Generation Diagnostic System (NGDS) Technology Development contract by the DoD after 12 months of competitive prototyping. The NGDS program will develop and deliver the new standard of biothreat detection to the US Department of Defense, replacing JBAIDS.
