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| The FilmArray system by BioFire Defense--Courtesy of www.labwrench.com |
The U.S. Food and Drug Administration has given a temporary thumbs up to Ebola test FilmArray BioThreat-E from BioFire Defense, a bioMérieux company. The test offers results in one hour rather than the one to two days required by existing methods.
The test runs on the BioFire FilmArray system, which is already in place at more than 300 hospitals, according to a Reuters story. The emergency use authorization does not constitute an FDA approval; it exists only for as long as circumstances require and can be terminated by the agency at any time.
"There is no adequate, approved, and available alternative to the emergency use of the FilmArray Biothreat-E test for diagnosing Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection," the FDA said in a statement to justify its decision.
The BioFire FilmArray is a polymerase chain reaction (PCR) molecular diagnostic instrument. BioFire said the emergency use authorization for the FilmArray Ebola test it the "the result of a long collaboration and close working relationship with U.S. Department of Defense," BioFire Defense CEO Kirk Ririe said in a statement.
"It is our mission to help improve public health and the rapid turnaround and ease-of-use of FilmArray will certainly be a great help for the healthcare professionals in the context of the Ebola outbreak," he added.
The test can be used with blood, or with urine in conjunction with blood. The agency defines the FilmArray Biothreat-E test as "an automated reverse transcriptase polymerase chain reaction system for the in vitro qualitative detection of Ebola Zaire virus." The test procedure includes nucleic acid purification followed by reverse transcription; it is a two-stage nested test that also includes a RNA process control. It takes about 5 minutes to prepare a clinical specimen after collection, with results available in one hour.
The next major diagnostics advance likely will be an Ebola test that can be used easily by healthcare workers in the field. Scientists are already working on paper-based tests that could offer fast and accurate results.
BioMérieux acquired BioFire Diagnostics in January for about $485 million. It then split it into two companies: BioFire Diagnostics and BioFire Defense. BioMérieux gained 2% on the news.
Investor Athyrium Capital Management backed BioFire with a $45 million capital infusion during 2013 and 2012, prior to the acquisition.
There are three FDA-cleared molecular diagnostics panels for the BioFire FilmArray system: a respiratory, blood culture identification and a gastrointestinal panel. The GI panel to identify common pathogens such as viruses, bacteria and parasites was cleared by FDA in May.
- here is the FDA letter (PDF) and the company release
- check out the Reuters story