This article has been updated from a previous version to clarify information about the contract BioFire was awarded.
BioFire Diagnostics said this week that it has inked a competitive prototyping contract with the US Department of the Army for the first increment of the Next-Generation Diagnostics System program.
NGDS is being developed by the Chemical Biological Medical Systems Biosurveillance joint product management office to provide a US Food and Drug Administration-cleared system to analyze clinical and environmental biological warfare agent samples. The CBMS-BSV is a branch of the Joint Program Executive Office for Chemical and Biological Defense.
The final system is intended to provide military healthcare providers with timely and accurate information to guide individual patient treatment and provide battlefield commanders with biological warfare threat information.
For increment one, BioFire will develop and optimize a panel on its FilmArray platform to detect biological warfare agents in blood or environmental samples. The FilmArray system will be evaluated during the competitive prototyping phase, and if it is selected, BioFire will receive a final contract to be awarded later in the year to further develop the system and seek FDA clearance for the panel.
The FilmArray system integrates sample preparation, nucleic acid amplification, detection, and analysis, and is designed to provide results in about an hour with about two minutes of hands-on time, according to the company. The instrument performs PCR to initially amplify nucleic acids from target pathogens, and uses melt curve analysis for multiplexed detection.
The FDA originally cleared the FilmArray panel along with a 15-pathogen respiratory panel in 2011, when the company was called Idaho Technology. In May 2012, the FDA granted clearance for five additional pathogens on the panel (PCR Insider, 5/15/2012).
The company is also developing several other infectious disease platforms for use in clinical diagnostic laboratories. In addition, BioFire has been heavily involved in the biodefense market, and has scored several contracts with US defense agencies to develop FilmArray for such purposes.
PCR Insider sister publication GenomeWeb Daily News originally reported the contract in February. According to the report, the US Department of Defense awarded more than $23 million to BioFire, Focus Diagnostics, and IQuum, all of which will compete to develop the FDA-cleared diagnostic platform for biological warfare agents.
The FDA also previously cleared two molecular diagnostic flu tests and a Q fever assay for use on BioFire's Joint Biological Agent Identification and Diagnostics System, or JBAIDS, a platform that Idaho Technology originally developed to identify biological warfare agents. The company developed these assays under contract from the US DoD.
"BioFire has a history of successful developmental efforts with the US Department of Defense, most notably with the [JBAIDS] program, and we are excited for this opportunity to demonstrate the capabilities of the FilmArray," BioFire CEO Kirk Ririe said in a statement.
He added that FilmArray and its associated comprehensive syndromic panels are capable of supporting the DoD's efforts to protect soldiers from environmental biowarfare threats and clinical threats.