NEW YORK (GenomeWeb) – BioFire Defense, a BioMérieux company, has been granted Emergency Use Authorization by the US Food and Drug Administration for BioThreat-E, a commercially available Ebola molecular diagnostic test for use in CLIA moderate- and high-complexity laboratories.
In addition, the firm's NGDS BT-E assay, which is intended for use in US Department of Defense laboratories, also received EUA. Both tests run on the PCR-based FilmArray platform.
Although many other firms have declared an interest in developing in vitro diagnostics for Ebola emergency use, the BioFire tests are the first Ebola IVDs from a commercial entity to receive authorization. In addition to the BioFire assays, three lab-based tests from the US Centers for Disease Control and the DoD were previously authorized to be used on patient samples.
The commercial test can be run on any existing BioFire FilmArray system and returns results in one hour. FilmArray platforms are "in routine use in over 300 hospitals" and thus the new authorization "instantly creates an extensive Ebola testing network in the United States," Randy Rasmussen, CEO of BioFire Diagnostics, said in a statement. BioFire Diagnostics and BioFire Defense are located in Salt Lake City, Utah, and are both subsidiaries of Marcy-l'Etoile, France-based BioMérieux.
BioThreat-E is designated for use on patients with signs and symptoms of Ebola virus infection who also have certain epidemiological risk factors. The test is authorized only for detection of Ebola Zaire, the strain detected in the current outbreak in West Africa.