The U.S. Department of Defense (DOD) has a long-standing history of developing medical countermeasures (MCMs) to combat deadly biological threats. Vaccines, diagnostics, and therapeutics serve in a fully-layered continuum of defense capabilities that both protect before exposure as well as to inform and treat after exposure. This set of capabilities also includes products intended to increase survival and health outcomes for service members in the event that deadly bacteria or viruses are manipulated and used as weapons of mass destruction (WMDs) or emerge from their natural sources.
Diagnostic products are included as MCMs because they play a key role in the treatment of military patients, providing information to both physicians and commanders about health-related events in their areas of responsibility. In fact, the diagnosis of an ill service member is likely the first indication that a biological event has occurred. Augmented situational awareness, such as evidence of a biological event, would translate into more effective decision-making, enhancing force health protection and ultimately resulting in improved health outcomes.
In 2013, the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) awarded a contract to BioFire Defense, LLC, to develop the Next Generation Diagnostics System 1 (NGDS 1), known commercially as the BioFire® FilmArray®, which is used in hospitals and clinical settings around the world for standard health care diagnoses such as gastrointestinal, sexually transmitted, and respiratory diseases. In 2017, the U.S. Food and Drug Administration (FDA) approved the use of the Warrior Panel, a DOD-funded diagnostic test, used in conjunction with the BioFire® FilmArray® for the diagnosis of anthrax, tularemia, plague, Q fever, and hemorrhagic fevers caused by Ebola and Marburg viruses. The Warrior Panel can diagnose diseases caused by all of these agents using only a small volume of patient blood. These advances drastically aid in protecting and treating our nation’s warfighters from biological threats they may encounter while operating in high-risk military environments.
However, the DOD is not the only federal agency that requires the development of these diagnostic MCMs. Various subordinate organizations in the U.S. Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), are similarly tasked with protecting the U.S. civilian population from these same biological threats. Due to the significant financial and time investments required to develop medical products, collaboration among government agencies, when opportunities and needs align, is highly desirable.
“No one organization working within the CBRN space can possibly do it alone,” said Col. Ryan Eckmeier, Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical). “It is critical that we leverage the expertise and resources of our like-minded partners to streamline the development of safe and effective medical countermeasures, getting them into the hands of the Joint Force faster.”
Recognizing the importance of rapidly diagnosing these particular biological agents in a traditional civilian medical environment, the CDC used an interagency agreement with the JPEO-CBRND’s JPM CBRN Medical to purchase BioFire® FilmArrays® and Warrior Panels in June 2018. In October 2019, the diagnostic system was made available to the CDC-managed Laboratory Response Network (LRN) as an integral operational capability.
The LRN is an integrated network of local, state, military, and federal laboratories with the infrastructure and capacity to respond to biological and chemical terrorism, as well as other public health emergencies. Initial BioFire® FilmArray® instruments and Warrior Panels were fielded to 16 high-priority domestic LRN facilities, enabling these labs to provide a unique and specialized public health and preparedness function and improving their overall response capability.
“Collaborations with federal agencies like the DOD are important for the LRN to stay on the cutting edge of emerging technology,” said Dr. Julie Villanueva, chief of the Laboratory Preparedness and Response Branch, CDC. “Deploying the Warrior Panel expands and streamlines the LRN’s capabilities to test for bio-threat agents and high-consequence pathogens. This is a good example of how we can leverage assets and investments across federal partners.”
Given the present-day CBRN global environment, fielding these diagnostics could not be timelier. An alarming increase in the use of chemical and biological weapons internationally, such as the now infamous Salisbury attack in 2018 using a deadly Novichok nerve agent, suggests that, for certain actors, the barrier to using these banned weapons is diminishing. In addition to these weaponized agents, parallel events where deadly biological pathogens emerge from their natural sources to infect human populations are also occurring. There is perhaps no better example of this than the SARS-CoV-2 pandemic.
In light of these growing concerns, and augmenting the CDC’s efforts, the JPM CBRN Medical extended its infectious disease preparedness partnerships beyond the federal government. In 2019, the JPM CBRN Medical entered into cooperative research and development agreements (CRADAs) to further position the BioFire® FilmArray® and Warrior Panel technology in laboratories at two well-renowned U.S. universities, both equipped with the medical expertise and physical infrastructure capable of successfully treating sick patients infected with high-consequence Biosafety Level 4 (BSL-4) pathogens, such as Ebola. The Emory University Hospital’s Serious Communicable Diseases Unit (SCDU), and the University of Nebraska’s Biocontainment Unit (NBU), were commissioned by the CDC to provide treatment for people affected by bio-terrorism or highly hazardous communicable diseases, and are considered leaders in steady-state operational readiness to address these pathogens.
Use of the BioFire® FilmArray® and Warrior Panel allows these facilities to accurately diagnose afflicted patients and provide specialized treatment. In fact, the Emory SCDU and the NBU have each successfully treated patients with Ebola virus disease and other hemorrhagic fevers. This capability benefits both the civilian and the military sectors, not only improving overall ability to care for patients who contract diseases that pose a significant individual and public health consequence, but also providing lessons learned from a clinical environment.
“The presence of these diagnostics in the health care setting greatly increase our ability to detect and treat potential threats in a clinically rapid manner,” said Dr. Colleen Kraft, associate professor at the Emory University School of Medicine. “This greatly assists clinicians in their diagnostic abilities – both to ‘rule-in’ concerning diseases and the reassurance of ruling out.”
More now than ever, the U.S. must develop and use MCMs to address not only biological and chemical weapons, but also emerging infectious diseases like the COVID-19 pandemic that is currently afflicting the globe. In addressing the pandemic, the FilmArray® has been relied upon heavily by both DOD and civilian medical institutions to keep up with an unprecedented testing demand.
The JPM CBRN Medical supported BioFire Defense, LLC, in the development of a COVID-19 specific test that is analyzed on the FilmArray®. This COVID-19 test, supported by the Office of the Assistant Secretary of Defense for Health Affairs using Defense Health Program funds, received an Emergency Use Authorization (EUA) from the FDA on March 23, and has since been used to test thousands of patients for COVID-19.
Collaboration between the DOD, other federal agencies, and non-governmental stakeholders, including academic institutions and industry partners, is an unequivocal public health force multiplier. Forging strong partnerships reduces costs, decreases the amount of time it takes to develop these critical products, and facilitates enhanced readiness and treatment for both service members and civilians alike.