Our Work on COVID-19 and Preparing for the Future
Three years since 2019 seems like a decade. In Dec. 2022, it will have been three years since the World Health Organization’s (WHO) China Country Office was informed of cases of pneumonia of unknown etiology (unknown cause) detected in Wuhan City. By Jan. 2020, our infectious disease experts were also actively monitoring what was at the time an outbreak. The cause was soon identified as a novel coronavirus named SARS-CoV-2 and the outbreak was named COVID-19. Only a few weeks later in Feb. 2020, we had been tasked with utilizing our Containerized Bio-Containment System to evacuate infected patients from a cruise ship. Soon after, following months of concern about its spread and severity, WHO then declared COVID-19 as a pandemic in March 2020.
Since that time, more than 6.5 million people globally have died from the disease.
In fact, as of this post, more than 300 Americans are still dying from the disease daily.
Some parts of the world still have not received the necessary diagnostics or vaccines to effectively control its spread or mitigate its impact on people. With an Oct. 2022 surge of cases in some European countries and vaccine uptake lagging in many countries, it is clear that the pandemic is not over.
Our Role in Combatting COVID-19
Our previous work in predicting, preventing, and controlling infectious disease outbreaks such as Ebola, SARS, and MERS helped establish our expertise, enabling our research experts to make diverse and significant contributions in combatting COVID-19. Through these efforts, we expanded and accelerated delivery of high quality clinical diagnostic products for customers who sought us out to support their respective diagnostic assay and detection device development.
Having dedicated our state-of-the-art Diagnostics Center of Excellence in late 2019, we were well-equipped to address a surge of new commercial and government projects focused on the testing, evaluation and regulatory aspects of COVID-19 diagnostics. This work moved several diagnostic devices through the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) process, enhancing the commercial availability of COVID-19 diagnostic products as companies achieve FDA clearance.
In the past few years, we have also played an important role in:
- Evaluating the efficacy and safety of vaccines and therapeutics, including efforts to discover new antiviral candidates and also support human clinical trials of medical countermeasures;
- Testing the effectiveness of several disinfectants and devices aimed specifically at decontamination of SARS-CoV-2. Testing included UV, ozone, hydrogen peroxide, and plasma technologies. Several of these technologies have proven 99.99% effective at reducing infection;
- Comparing the performance of several rapid COVID-19 antigen tests for efficacy of detection of SARS-CoV-2 variants as they emerged;
- Verifying the effectiveness of drug candidates in in vitro tissue culture assays against SARS-CoV-2. Several drugs have progressed to the FDA for clearance as potential treatments of COVID-19;
- Using a cell culture assay to determine the effectiveness of clinical specimen transport media for inactivation of the virus while preserving nucleic acid for use in NAAT diagnostic assays (e.g. RT-PCR); and,
- Supporting workplaces, campuses, and businesses by assessing programs for risks and biosafety, enabling their return to in-person activities.
Another research project we supported was to determine whether SARS-CoV2 on environmental surfaces could be detected using RT-PCR assays. This work could be useful in detecting presence of the virus in areas like those used for food preparation or in a healthcare facility, or to demonstrate the efficacy of cleaning or decontamination procedures in those same areas.
Most recently and in a breakthrough for SARS-COV-2 diagnostics, we played a key role in research on the design, development, testing, and validation of a multiplex panel that detects five major variants of concern – Alpha, Beta, Gamma, Delta, and Omicron – on a portable platform. This advancement enables extended availability of rapid, accessible, and portable genotyping capabilities to low resource settings around the world, as the assays provide quick results, can be stored at room temperature, and are utilized on handheld PCR devices.
Hear and read more about our response to the COVID-19 pandemic in this edition of MRIGlobal’s Gray Matter podcast, featuring a conversation with Kristine Werking, Portfolio Director II and Hillary Wood, Program Manager. You can also read more about our infectious disease response work in this interview with Werking via Bionexus KC.
Use of High-Containment Biosecurity Laboratories
Our work related to COVID-19 has taken place in our laboratories, including those that are BSL-3, which are considered High-Containment Biosecurity Laboratories (HCBLs). In these laboratories, our researchers have supported testing and evaluation for various government and commercial partners to aid in obtaining regulatory clearances for devices and assays. This work has demonstrated the strength of our laboratory diagnostic capabilities and ability to scale up operations during surge demands for COVID-19 testing.
Besides COVID-19, HCBLs will continue to be a critically important tool not only for responding to infectious diseases, but also in infectious disease surveillance programs that then help support tracking and predicting patterns and trends of infectious disease to augment preparedness and readiness.
At-Home Testing Is on the Horizon
As infectious diseases spread, some people may have the disease without showing any signs, which can be detrimental to containment. Such asymptomatic carriers typically go about their usual activities, allowing the pathogen to spread to others.
The need to maintain social distance during the pandemic accelerated the development and adoption of at-home testing for COVID-19. Future diagnostics development could lead to at-home testing for other infectious diseases, allowing for more widespread and adequate testing. With these tools in place, people will be able to test themselves before or at the first sign of symptoms and for a variety of diseases. Following diagnosis, they can then take the necessary steps to contain the spread of the disease before passing it on to others.
MRIGlobal’s Contributions to the American Pandemic Preparedness Plan
With the goal of promoting innovation, augmenting pandemic preparedness, and prioritizing investments, the White House established the American Pandemic Preparedness Plan (AP3) in Sept. 2021. According to AP3, its goal is to achieve transformational capabilities according to five pillars:
- Transforming our medical defenses;
- Ensuring situational awareness;
- Strengthening public health systems;
- Building core capabilities; and,
- Managing the mission.
The plan cites examples of implementing transformational capabilities that MRIGlobal has worked on, especially in the areas of disease diagnostics and medical research portfolios.
Our work in disease diagnostics has contributed to several FDA EUAs, a 510k through BARDA and NIH Rapid Acceleration of Diagnostics (RADx), and the follow up Independent Test Assessment Program (ITAP). Our team also supports projects that DoD Chemical & Biological Defense Program funds through Joint Science & Technology Office for Chemical and Biological Defense (JSTO-CBD) and Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND). These and related activities are reinforced by our strong public-private partnerships with government and commercial industry entities.
We have also supported biosecurity items listed in the plan, such as Global Health Security Agenda and agricultural biothreats like African Swine Fever.
Preparing for What’s Next
The past three years have been devastating to global public health. To learn from this experience, the global public health community must support a more effective response to future outbreaks, epidemics, and pandemics by focusing on research that enhances response preparedness and development of medical countermeasures – including disease diagnostics, biosurveillance, and therapeutics – for future use. Such work will help reduce the likelihood of another pandemic in the future.
The White House also released their National Biodefense Strategy and Implementation Plan in Oct. 2022, providing objectives and priorities for countering biothreats, enhancing pandemic preparedness, and achieving global health security. The Plan defines biodefense, which MRIGlobal capabilities have supported for more than 25 years, as “actions to counter biological threats, reduce biological risks, and prepare for, respond to, and recover from biological incidents, whether naturally occurring, accidental, or deliberate in origin and whether impacting human, animal, plant, or environmental health.” Similar to AP3, our work, which is grounded in understanding the spectrum of biological threats, has also contributed to biodefense across implementation with partners in areas such as biological risk management and One Health approach, and achieving goals for enabling detection, ensuring enterprise capabilities, and aiding response and recovery. Our significant history of biodefense expertise since before the 2001 anthrax attacks has continuously demonstrated our capabilities to counter biological agents, whether accidental, intentional, or naturally occurring. We will continue to be actively involved with leading such work, especially as it relates to chemical and biodefense programs.
GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal to further understand our work in infectious diseases. We offer a broad portfolio of infectious disease testing assays and capabilities across diagnostic disciplines, from screening and diagnosis to genotyping, therapy, and monitoring. Those seeking analysis of infectious disease tests can trust in our breadth of experience and knowledge – not just on the subject matter, but FDA protocols as well.
To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.
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