Rapid Diagnostics Defend Against Biological Threats
September 22, 2023
The impact of biological threats to the warfighter and to America’s readiness is significant. Consider the COVID-19 pandemic rendering the Littoral Combat Ship, USS Milwaukee, and Aircraft Carrier, USS Theodore Roosevelt, out-of-commission after thousands of sailors developed infections, disrupting deployments, keeping ships in port, and challenging the readiness of the U.S. Navy.[1] COVID-19 was hardly the first time the United States was concerned with the impact of disease on the warfighter. In World War II, nearly 18,000 servicemembers were removed daily due to disease spread.[2] In the Iraq War, military personnel reportedly brought home highly-resistant complex infections routinely.[3] Quite simply, rapid spread of disease threats could be nearly as devastating as a conventional strike to the warfighter.
The challenge of biological threats to the warfighter is not limited to only naturally occurring contagions or traditional public health concerns, such as influenza, but of manufactured, engineered biological threats that have the potential to devastate populations. The U.S. Department of State Arms Control Report continues to warn against foreign adversaries developing complex biological weapons, as had the Office of the Director of National Intelligence.[4] For these concerns, the United States Government continues to invest billions of dollars annually, across the U.S. Strategic National Stockpile to the Department of Defense, to support medical countermeasures for these threats.[5]
The challenges of devastating biological threats spans engineered viral, bacterial, and fungal agents, oftentimes of unknown origin and genetic makeup. Without the opportunity for rapid diagnostics that span the spectrum of threats, identification of unknown pathogens and eventual spread of disease becomes a crippling challenge that has potential to shape America’s readiness. The U.S. Air Force AFWERX has remarked that rapid “Far-Forward Infection Diagnostic Improves Mission Readiness and Warfighter Health” when referencing their investment in GeneCapture’s rapid diagnostic platform that seeks to achieve this mission.[6]
The standard of care for diagnosis of unknown pathogens is largely limited to standard laboratory testing.[7] While laboratory-based diagnostics were useful in identifying coronaviruses from similarly-presenting agents, they also revealed a vulnerability in America’s response. The time to develop readily available diagnostic tools took considerable time, rendering millions of sick patients without any opportunity to confirm a COVID-19 diagnosis and seek treatment.[8] The utilization of a single-indication diagnostic, rather than a broad spectrum diagnostic across a field of pathogenic threats, prevented rapid identification of non-COVID-19 agents, such as influenza, in these same patients. Days-long delays to diagnosis and complex laboratory requirements drove timelines to resolution[9], requiring long quarantines for non-COVID-19 patients while delaying antibody treatments for those who required a formal COVID-19 identification and diagnosis.
The case during COVID-19 for rapid diagnostics can be broadly extrapolated across the spectrum of biological threats. A growing pathogenic portfolio, with the increasing risk of engineered and unknown contagions, represents concerns that one of these threats may be weaponized and deployed with no available diagnostic to identify it.
Risk scenarios around this threat oftentimes suppose that symptoms of some attacks may appear as more traditional symptoms, such as the Anthrax threat. In this instance, a clinician without a rapid diagnostic tool may treat an inhalation alert Anthrax patient as if they are a traditional patient presenting with conventional pulmonary symptoms and send the patient home, delaying administration of life-saving Anthrax anti-toxin medical countermeasures.[10] By the time Anthrax is identified, the pathogen may have reached the fulminant stage of presentation. The Anthrax example is hardly unique: in the instance of a weaponized botulism toxin event, rapid identification of the threat is generally required to receive live-saving medical countermeasures. In this instance, clinicians may delay administration of these countermeasures without positive identification of the toxin, due to its serious side effect profiles.[11]
Risk scenarios become incredibly challenging for Pathogen X - when the pathogenic threat is unknown, robust, and deeply contagious - such as an agent with the pathogenicity of Anthrax, but as contagious as COVID-19 - rendering the utilization of a flexible, adaptable, rapid-acting, and broad-spectrum diagnostic tool mission-critical in the fight against these threats.
GeneCapture, the Huntsville, Alabama-based company developing a rapid diagnostic platform with these characteristics, has recognized these challenges. GeneCapture, at a Technology Readiness Level of 5/6, is advancing in its development of a portable, adaptable rapid diagnostic that can screen for over 200 pathogens in under an hour. Additionally, GeneCapture has developed highly complimentary Antibiotic Susceptibility Testing capabilities as a companion to the platform, to enable the selection of the antibiotic of best fit to match the pathogen identified. GeneCapture’s solutions are designed to be field-deployable, inexpensive, require minimal training, and possess broad-spectrum testing abilities.
The hypothetical utilization of GeneCapture’s platform may have quickly identified COVID-19 on the USS Theodore Roosevelt, enabling rapid quarantine of unknowingly infected sailors, keeping the ship deployment-ready and infection spread at bay. Furthermore, the utilization of GeneCapture’s platform in the field could potentially support diagnosis of a biological attack on the warfighter, allowing for faster treatment and return to service. Capabilities like GeneCapture’s platform present civilian application as well; there is opportunity for utilization in point-of-care capacities for conventional public health indications, such as Urinary Tract Infections or Influenza.
While GeneCapture is seeking to raise an additional $5-6 million in their race to their upcoming submission for FDA clearance, the company has significant momentum. They recently announced raising nearly $8 million in non-dilutive support from the Department of Defense,[12] who recognizes the potential application of the GeneCapture technology as a mission-critical tool in the Department’s interest of maintaining readiness while providing another tool in their arsenal against crippling disease spread among the warfigher.
Learn more about GeneCapture’s recent advances today: GeneCapture.com
[3] https://www.nytimes.com/2005/08/04/us/troops-in-iraq-bring-resistant-bacteria-home.html
[7] https://www.mayoclinic.org/diseases-conditions/infectious-diseases/diagnosis-treatment/drc-20351179
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8440261/
[9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7819504/
[10] https://elusys.com/wp-content/uploads/2022/08/Yamamoto-et-al.-2016.pdf
[11] https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm
[12] https://www.genecapture.com/news/blog-post-title-two-46rfn
View the entire case study here.