BARDA is partnering with BioFire Defense, LLC to develop the FilmArray NGDS Warrior Panel, a molecular test that will be designed to identify six common biothreat pathogens. Under this contract, BioFire Defense will advance the development of this panel for use on their BioFire FilmArray Torch System with additional studies and request U.S. Food and Drug Administration (FDA) 510(k) clearance.

Select agents, as defined by the U.S. Centers for Disease Control and Prevention (CDC), are biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products. In a public health emergency involving high-consequence pathogens, a rapid and accurate national testing capability will be crucial for health security and to minimize public health impacts and economic disruption.

Obtaining FDA clearance to use the FilmArray NGDS Warrior Panel on the BioFire FilmArray Torch System can significantly increase the national biothreat test capability which would be critical in response to a biothreat emergency. The FilmArray NGDS Warrior Panel is a nucleic acid amplification test panel for in vitro diagnostic use on the easy-to-use BioFire FilmArray Torch System.

The test is intended to detect the presence of six biothreat pathogens – including the organisms that cause anthrax (Bacillus anthracis), plague (Yersinia pestis), tularemia (Francisella tularensis), Q-fever (Coxiella burnetii), and Marburg and Ebola virus diseases – in whole blood, positive blood culture and sputum, and is designed to provide results in approximately an hour.

The FilmArray NGDS Warrior Panel is currently FDA-cleared for use on BioFire FilmArray 2.0 System only. With BARDA support, BioFire will complete bridging studies and obtain 510(k) clearance to allow the assay to be run on the BioFire FilmArray Torch System, which makes up approximately 70% of BioFire’s FilmArray System install base, thus substantially expanding testing capability across the U.S. The BioFire FilmArrayTorch System also provides increased testing throughput compared to the BioFire 2.0 System.

Supporting the advanced development of such crucial diagnostics through regulatory clearance helps bolster national preparedness capabilities and protects people from the consequences of deliberate or naturally occurring outbreaks of these biological threats.

This award is one component of the BARDA’s DDDI’s Division medical countermeasure portfolio.