Tools capable of rapidly detecting the presence or absence of previously unknown pathogens are essential for an effective defense against future pandemics.
As a first step towards the use of such tools, the Science and Technology (S&T) Directorate of the Department of Homeland Security (DHS) is investing in new technology capable of distinguishing between bacterial and viral infections using only one drop of blood per patient.
The hope is that by the time another major biological event – whether intentional, accidental, or natural – comes knocking on our door, the United States will be able to quickly triage people for their next stage of medical care. . Thanks to this technology, front-line medical staff could use it to quickly determine the presence of viral or bacterial infections in people and thus better protect themselves, triage patients and allow transit passengers to travel.
To make this a reality, S&T is working with the Center of Excellence for Cross-Border Threat Detection and Supply Chain Defense (CBTS) and two leading biotechnology companies to develop a platform for the detection / diagnosis of virus against bacteria called the Host Response Test System (HRTS). It includes a rugged portable device that can differentiate bacterial and viral infections within an hour, even in pre-symptomatic patients. S & T’s primary interests in funding the HRTS effort are to help accelerate the development of pathogen agnostic detection technology and to support interagency partners who have medical authority.
“Long before COVID-19 was on anyone’s radar, S&T saw the importance of performing better biological monitoring,” said CBTS director Dr. Gregory Pompelli. “S&T wanted to make sure we had this tool for DHS and others, recognizing that we need better monitoring of biological threats. “
CBTS has partnered with two companies: Predigen Inc., which developed the biomarkers that indicate the presence of viruses or bacteria, and Biomeme, Inc., which developed the Franklin ™ thermal cycler test instrument to measure these biomarkers.
“Identifying potentially ill passengers and DHS personnel earlier means they are less likely to spread infectious diseases and can receive treatment sooner,” added CBTS Executive Director Dr Heather Manley Lillibridge. “The Food and Drug Administration has granted emergency use authorization for the detection of SARS-CoV-2 on the Biomeme instrument. In work done at Duke University and supported by the National Institutes of Health and the Antibacterial Resistance Leadership Group, Predigen bacterial / viral tests have been evaluated in 1,200 patients in the United States with acute respiratory disease.
HRTS will help DHS mitigate biological events that impact national security, including those that may negatively impact the national economy, critical infrastructure, or could overwhelm state response capabilities and local. In addition, HRTS will mitigate the impacts of communicable diseases on DHS staff, interagency partners and the public.
“DHS is investing in the further development of the HRTS Predigen / Biomeme which can be used in both biodetection systems and homeland security-related medical diagnostics,” said Dr Lloyd Hough, who heads the Technology Center of S&T risk awareness and characterization (HAC-TC). “Our civilian population and our economy would benefit greatly if HRTS units were brought closer to where they are needed most. And if the system is widely available, it can help mitigate a future outbreak and even prevent a pandemic. “
HRTS will quickly identify viral / bacterial infections
When another outbreak of contagious disease strikes, medical first responders will once again be on the front line. HRTS could help first responders screen people for signs of infection, even if those screened are asymptomatic.
“The portability of the technology allows you to use it anywhere,” said Dr. Ephraim Tsalik, chief researcher at Predigen and associate professor of medicine at Duke University. “It serves as a tool to identify people who may be sick and don’t even realize it. “
When a person is exposed to a pathogen, distinct changes in the genes of immune cells are triggered, changes specific to viral or bacterial infections. HRTS takes advantage of this phenomenon. Specifically, HRTS uses quantitative polymerase chain reaction (PCR) technology to measure the extent to which specific genes related to the immune system (biomarkers) are turned on or off (gene expression), and these gene expression signatures indicate whether viruses or bacteria are the cause of infection. . Predigen scientists at Duke University initially identified these biomarkers to detect and distinguish bacterial infections from viral infections in a single drop of blood. HRTS could also identify a person who is exposed to a virus but not yet symptomatic. A critical window exists between the time of exposure to the virus and the time a person becomes ill from the infection, which can take several days. And since a patient’s immune response to the virus is measured and not the virus itself, HRTS is ideally suited to identify emerging viral infections before testing for this new virus becomes widely available.
“Since the immune system responds to pathogens within hours of exposure, these biomarkers could be detected days before symptoms appear. This is a much better screening tool than taking a temperature or other symptoms that are measured regularly, ”Tsalik said. “For the S&T project, we are adapting Biomeme’s thermal cycler technology to measure gene expression signatures.
The Biomeme thermal cycler was initially created in 2007 for the testing of environmental and veterinary pathogens in the field. Over the past decade, it has evolved into a pre-symptomatic test. Biomeme and Predigen began working together on HRTS in 2018, and S&T began funding them in April 2020. According to Biomeme, no technological changes were required to embark on this HRTS effort.
Biomeme’s thermal cycler can simultaneously detect and quantify 27 biomarkers. Predigen’s host response tests require 24, leaving room for up to three additional targets, including SARS-CoV-2 or the influenza virus. Biomeme and Predigen are currently working on two host response tests for S&T. One, called PreViral, can identify a presymptomatic viral infection. The second test, called Bacterial / Viral, can distinguish between bacterial and viral infections.
“While DHS is not involved in the development of human diagnostics per se, our mission is to advance technologies that can be used for bio-sensing and support the resilience of the American Homeland,” said Hough of HAC- TC. “HRTS advances the technological paradigm for pathogen agnostic biodetection and diagnostics that could one day be used to meet the needs of DHS at deployed sites. “
“DHS is concerned about the next unknown pathogen that threatens our national health security,” Hough added. “This is why we support the integrated development of the Predigen assays, which can discriminate against viral and bacterial diseases and use reagents suitable for a harsh environment, and Biomeme’s rugged machine, on which these tests are run. In the future, we may be able to push the capabilities of HRTS and its reagents to meet other DHS biosensing needs or even as a screening solution for border security. “
A working HRTS prototype could be ready within a year
S&T is now halfway through this effort, and researchers are currently optimizing bacterial and viral signatures and verifying that all Predigen assays are compatible with the Biomeme instrument, which includes the built-in HRTS. Next, the CBTS will validate how well the tests distinguish between viral and bacterial infections, as well as pre-symptomatic people. S&T also strives to ensure that HRTS is affordable, so that it can be widely adopted for screening before prescribing antibiotics.
“The partnership with S&T has been very valuable to us,” said Pompelli. “This project demonstrates the value of the S&T policy of investing in good research. “
HRTS could also be useful for other federal agencies. For example, the Department of Defense could use it to control troops before deployment, and the National Aeronautics and Space Administration could control astronauts before Space Shuttle missions. Further, Tsalik adds, “Once these host response tests have undergone rigorous analytical and clinical validation, they will finally give clinicians the information they need to know with confidence when to use antibiotics.”
“The focus of DHS’s Centers of Excellence on basic research pushes the boundaries of science and technology to support the homeland security mission,” Hough said. “And this project is a perfect example. “
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