The Emergence of New Diseases Drives Innovation
Infectious diseases have been a threat to humans throughout recorded history. Plagues caused by the bacterium Yersinia pestis have killed tens of millions of people, most notably in the Mediterranean Basin, Europe, and the Near East from 541-549 (known as the Plague of Justinian), in Western Eurasia and North Africa from 1346-1353 (known as the Black Death), and in Hong Kong in 1894. In each case, humans often became infected after being bitten by a rodent flea carrying the plague bacterium or by handling an animal infected with plague.
Tuberculosis has been infecting people for thousands of years and continues to devastate populations around the world today. Prior to COVID-19, Mycobacterium tuberculosis (Mtb) – the causative agent of tuberculosis – was the leading cause of death globally due to an infectious disease. In 2019, approximately 10 million people contracted the disease and it killed 1.4 million of them. As COVID-19 mortality figures are now decreasing worldwide, Mtb mortalities are rising once again. WHO’s annual TB report estimates that tuberculosis killed 1.6 million people in 2021, exceeding the estimated 1.5 million deaths in 2020.
While infectious diseases aren’t new, where, how, and sometimes even which diseases are emerging to threaten public health are all evolving. Due to global trade and travel, climate change, and other factors, the risks have increased substantially in recent decades. Today, pressing viral, bacterial, soil, and vector-borne diseases are each formidable. And it is only a matter of time until a new one emerges to threaten human health.
Emerging Viral Threats
Viruses cause human suffering both in acute and chronic diseases, with one estimate suggesting that scientists have identified as few as 4,000 of the estimated 1.67 million viruses thought to exist on earth. Many of these unknown viruses are zoonotic, or capable of “spillover” transmission from animals to humans at any time. Today, the most well-known virus of this type is SARS-CoV-2, the virus that causes COVID-19. Technically, the virus is not classified as zoonotic, as the animal reservoir has not yet been confirmed, so the World Health Organization instead refers to it as an “emerging infectious disease of probable animal origin.” This disease has killed more than 6.5 million people globally and infected approximately 631 million. Strong evidence points to a seafood market in Wuhan, China as its epicenter. While the virus is believed to have originated in bats, a well-known vector for many zoonotic diseases, positive environmental samples indicate that it jumped to a raccoon dog housed at the market. Native to East Asia and sold for meat and fur, the animal likely then spread the disease to a human host.
In this era of globalization, mpox (formerly known as Monkeypox) grabbed headlines in mid-2022, starting with a British resident who had travelled to Nigeria. Over the next seven months, more than 80,000 cases would be reported globally, with nearly 30,000 of those reported in the U.S. Though the natural host for mpox is yet to be identified, its cause is likely a rodent which then came into contact with monkeys, resulting in a viral spillover event. Following outbreaks in 2014-2016 in Guinea and Sierra Leone, and a Sept. 2022 outbreak in Uganda, Ebola virus disease (EVD) became another virus of global interest, with more than 150 people infected and more than 50 having died. Humans can become infected with EVD through direct contact with an infected animal (bat or nonhuman primate) or a sick or deceased person infected with Ebola virus.
Malaria is another serious and sometimes fatal disease. It is caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness. Only about 2,000 cases of malaria are diagnosed in the United States each year, with the vast majority of cases being in travelers and immigrants returning from parts of the world where malaria transmission occurs. Unfortunately, the World Health Organization estimates that in 2020, 241 million clinical cases of malaria occurred, and 627,000 people died of malaria, most of them children in Africa. Research shows that climate change could increase transmission of malaria and other mosquito-borne diseases because of an increased spatial range and length of the transmission season, placing a greater proportion of the global population at risk.
In the future, an unknown virus – zoonotic or not – could rapidly spread globally.
Emerging Soil Threats
The thick subsurface layer of soil that (historically) remains frozen throughout the year, permafrost is thawing due to climate change. Researchers have been raising questions about whether infectious disease risks could possibly emerge or re-emerge from higher latitudes, including from melting Arctic ice and thawing permafrost. It is well known that anthrax forms spores (Bacillus anthracis is the bacterium that causes anthrax) that can persist for decades and remain viable to cause disease, but this phenomenon may now be exacerbated by permafrost thawing. In addition to this known, observed threat, there is growing speculation about other types of bacteria and viruses that could emerge from ice and permafrost.
Climate change is also driving increased fungal threats, as it makes some environments more hospitable and conducive to their presence. In one research study, which focused on an endemic fungal spore in the soil that causes Valley fever, an increase in precipitation in previous years was found to be was found to be the dominant predictor of disease in all seasons. Another study showed an increase in Penicilium marneffei, a fungus that occurs naturally in the soil and affects mostly immunocompromised people, during rainy months.
Emerging Vector-Borne Threats
Studies provide evidence that climate change has also contributed to the expanded range of ticks and mosquitoes, with these disease vectors potentially increasing their range by hundreds of miles over many generations. As they spread, they expand the geographical distribution of the new and emerging diseases they carry with them. This increased range makes vector-borne diseases like dengue, Zika, Rocky Mountain spotted fever, tularemia, and others an emerging threat to human and wildlife populations.
Our colleague Dr. Joseph A. Russell, Ph.D., recently led a team to biosurveillance of tick- and mosquito-borne diseases. Following sample collection, the team conducted sequencing on the tick samples while still in the field. Because researchers in field environments can be impacted by the elements and natural threats – in this case wild alligators and rattlesnakes – the team wanted to move quickly and get real time results in as little as 90 minutes, with findings that were unexpected and may surprise you.
Disease Biosurveillance and Diagnostics
To mitigate the impact of these and other threats, innovative tools are necessary. Working with partners, we are developing a CRISPR-based diagnostic technology that will provide next-generation detection for our customer, combining gene-editing technology with fieldable diagnostics and biosurveillance. Our innovative work aims to leverage advances in gene editing technologies to develop field-forward diagnostic and biosurveillance technology that enables rapid detection of zoonotic and other viruses, bacteria, host biomarkers, and other diseases, anytime, anywhere. In collaboration with partners, we are working to design, develop, prototype, and deploy a novel nucleic acid detection device. This is a massively multiplexed detection (MMD) device for 1,000 or more targets in a variety of different sample types, including respiratory, soil, serum, and vector-borne. The goal is for this MMD device to be simple to operate, low-cost, and rapidly reconfigurable to provide high-impact, high-quality, and trusted information that enhances decision-making and concomitant action. As a result, it will improve the speed and efficacy of triage and treatment, thus augmenting the standard of care for the military and public health domains in austere environments.
New Laboratory Support for FDA 510(k) Submissions
Citing customer interest in achieving permanent market access through FDA’s 510(k) approval process, enabling market approval and access for their products, we have opened a new lab developed specifically for this purpose. It was designed to host the Roche Diagnostics cobas® 6800, which is a fully automated, highly sensitive, sample to answer platform capable of running more than 20 Roche diagnostic assays. These include respiratory, blood-borne disease, sexual health, and transplant assays.
This instrumentation, in combination with our Hologic Panther Fusion® and other FDA cleared molecular diagnostic platforms, enables our customers access to high quality assays in a very timely manner and the flexibility to work on many different diseases and evaluate a variety of different products, including antigen tests and full-size sample enhancer molecular tests. This will help our customers prepare for the future and address whatever the next emerging infectious disease is.
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 support to advance the research, development, and validation 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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