Although the pandemic isn't over yet, the question of future pandemics is still on the mind of many infectious disease experts.
With that in mind, Abbott is using its infectious disease experience, building on its Global Viral Surveillance Program for HIV and viral hepatitis research, to spearhead a coalition that will prepare for disease outbreaks, particularly those that haven't yet happened and pathogens that have yet to be discovered.
According to Gavin Cloherty, the head of infectious disease research at Abbott, the Abbott Pandemic Defense Coalition is "the culmination of several years of preparation" that has grown from the global surveillance program.
The coalition is a "holistic program" in which Abbott will work with a variety of collaborators to form a network to identify emerging pathogens and then create diagnostic tests for them, Cloherty said. As its global surveillance efforts have evolved, Cloherty said Abbott has focused on the "three C's": building up its capability to find new viruses, building capacity to find viruses at scale, and collaborating to identify and react to those potential threats.
If physicians in the field notice a novel pathogen, they can collect samples to send to Abbott's partners in the coalition for next-generation sequencing and various diagnostic testing to determine if it is a potential threat. Many of those physicians belong to the collaborating organizations and are experts with a "discerning eye … able to see the unusual case in front of you, or trends in a patient population, and then investigate it further," Cloherty said.
For those potential threats, Abbott can use its diagnostic capabilities to quickly build prototype tests for various modalities depending on the threat, including PCR-based central laboratory tests or rapid point-of-care tests, Cloherty said. Those tests can then be deployed throughout the global network through the collaborators to determine whether the pathogen has spread across the world.
Those collaborators include the Colombia/Wisconsin One-Health Consortium at the Universidad Nacional de Colombia,; the faculty of medicine at Siriraj Hospital at Mahidol University in Thailand; the Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formations in Senegal; KRISP at the Genomic Centre of the University of KwaZulu-Natal in South Africa; the Rush University System for Health in Chicago; the University of the West Indies in Jamaica,; Universidade de São Paulo in Brazil; and YRG Care in India.
These initial partners are only the beginning of the coalition, and Abbott is continuing search for collaborators across a broad range of geographic regions, Cloherty said. With the current partners, "we are represented in the critical geographies, particularly ones where novel pathogens tend to pop up." All of the partners are well recognized and have access to other physicians and health systems, with Cloherty adding that doctors in these areas will "know who they can come to" if a patient presents with suspicious symptoms, although the process might look a little different depending on the country.
"These partners are experts in their own right and are working in this space, but they also are identified within their communities as people that others can approach with an unusual sample to get some additional analysis," he said.
For example, at the Rush University System for Health in Chicago, surveillance will be the main role, both looking for known pathogens in the area and setting up surveillance programs throughout the medical center system to identify unknown pathogens. According to Alan Landay, professor and vice chairperson for research in the Department of Internal Medicine at Rush Medical College and principal investigator at Rush University Medical Center, the organization is setting up clinical, laboratory, and radiological parameters to serve as alerts in the system's electronic health record for a patient who may be infected with an infectious pathogen. Rush would then take samples from that patient and refer them to Abbott for sequencing.
Multiple departments are involved in setting those parameters, which include pulmonary symptoms and hematology measures like nutraphil-to-lymphocyte ratios, and will be monitoring for patients who meet the criteria, including pulmonary medicine, hepatology, and infectious disease. Landay said Rush is also working with its internal medicine group for patients on not only the system's main campus, but also satellite care centers and clinical sites throughout the metropolitan area and suburbs.
Flu-like illnesses or other coronaviruses "seem to be what spread rapidly" and will likely be the focus at Rush to start, Landay said. But the health system is "keeping an open mind" and has included other clinical services to keep its eyes out for other "hepatitis-type viruses" or gastrointestinal or liver viruses, he added. "We're going to cast a very broad net here at our own population in Chicago and at Rush to look across all the different domains to find … novel viruses and unknown pathogens."
Although Landay said Rush is looking more at respiratory and flu-like illnesses, Cloherty said Abbott is focusing on broad infectious diseases in humans, specifically diseases of unknown origins and emerging and reemerging pathogens.
Rush has also begun setting up a data commons in the cloud it hopes the coalition's partners can enhance, which would allow the sharing of information from around the world about unknown pathogens, such as the clinical-presenting features of a pathogen in different geographical areas.
Cloherty said Abbott is engaged in "capacity building" with many of the collaborators to ensure there is consistency across the coalition, namely by sharing the techniques it has developed through its Global Viral Surveillance Program. Scientists from the partner institutions will work closely with Abbott to find more information about unknown pathogens and undiagnosed ailments.
The coalition will also use a hybrid sequencing model, where laboratories at the site where the pathogen is found or Abbott itself can analyze the sample. Multiple laboratories can also analyze the same sample to get as much information as possible about it and ensure nothing is missed. Collaboration is a key component of the coalition, Cloherty said. "What was inspirational about the COVID-19 pandemic was what happens when everybody's pulling in the same direction," he said.
The possibilities will also depend on the partners' specific areas of expertise, such as immunology or data analytics. KRISP, in South Africa, has extensive experience with phylogenetics and will be able to train other partners and broaden the knowledge of phylogenetics and bioinformatics in the coalition, Cloherty said. "Different people bring different capabilities to the table … we're going to definitely leverage that," he said.
Once travel restrictions are lifted, some of that training can be done at Abbott, with scientists coming to the company to learn its techniques and bring them back to their organizations, he added.
Cloherty said Abbott was spearheading the coalition as a "response to a public health need," since the current pandemic has shown the "critical role that industry plays in partnering with public health."
"We are taking a central role in convening this and I think we've demonstrated a value that we bring to the table … both in SARS and in the Global Surveillance Partners." Abbott is funding the program as it stands, Cloherty said. The company declined to comment on the funding amount.
Despite its lead role in the program, Cloherty said Abbott is open to additional partners and wants to collaborate with others in the field. "We're not an island and everybody needs to be working together," he continued.
The goal of the coalition is not to stop outbreaks entirely, but rather to keep them from snowballing. "Outbreaks can happen, and they will happen, and we've seen that time and time again, but if we can try and contain it together, working with these partners, working jointly with public health, I think we stand a better chance of containing it and maybe preventing the next pandemic," he said.
The firm's experience with its Global Surveillance Program has provided it with a foundation to build the coalition on, Cloherty said. In 1994, the Global Viral Surveillance Program was created after a novel group of HIV infections, the HIV group O infections, was discovered and created a problem for many HIV diagnostic tests. The O group caused concern because it couldn't be detected by early versions of HIV-1 test kits. "Abbott realized that we needed to put something in place to make sure that that doesn't happen again," he continued.
Cloherty said that through the program, a new case of second human pegivirus was recently discovered, as well as a new strain of HIV-1 Group M, subtype L. The program has worked to sequence samples from patients with HIV to understand levels of genetic diversity, and has expanded to look at other factors, such as prevalence, as well as other diseases like hepatitis. The program will be a component of the coalition and Abbott will continue to look at known pathogens in addition to other pandemic threats, Cloherty said.
Cloherty also emphasized the importance of a quick response to potentially deadly pathogens in order to stop them in their tracks, which Abbott's expertise in the diagnostic field can assist with. "One of the things that's become clear from COVID is how critically important diagnostics are, particularly in something that's emerging, as the first line, the first tool, that can be used by physicians and public health to try and contain it," he said.
Abbott has a proven ability to rapidly develop and commercialize diagnostic tests, as evidenced by its suite of SARS-CoV-2 products that were available within weeks of the virus' appearance in the US. Abbott's RealTime SARS-CoV-2 test received Emergency Use Authorization from the US Food and Drug Administration in March, the same week early tests from Roche, Thermo Fisher Scientific, Hologic, Laboratory Corporation of America, and Quidel received EUA.
Abbott's ability to create prototype tests quickly is a benefit for the coalition, Cloherty said, as the firm was able to look at one sequence for SARS-CoV-2 and design the assay in a matter of weeks. It took the company "one or two days" to design the primers and probes for the test, Cloherty said. Obviously, the speed will "depend on the pathogen, and on what we find, and on the technology," but Abbott has "shown that we can react very, very quickly."
There are other partnerships and initiatives using diagnostics for pandemic preparedness, including the Foundation for Innovative New Diagnostics' pandemic preparedness program and the University of Washington's Alliance for Pandemic Preparedness, although they don't follow the same guidelines as Abbott's coalition.
FIND's program draws on the World Health Organization's R&D Blueprint, which lists high-priority pathogens that could spark an international public health emergency. FIND is working with its partners to strengthen diagnostic preparedness across the blueprint pathogens, along with dengue fever, yellow fever, and bacterial meningitis. According to its website, the organization is identifying technical solutions that can close R&D gaps, such as platforms that can run diagnostic tests for multiple pathogens; improving response speed by making sure partners can conduct clinical trials at short notice; and supporting market sustainability by finding new financing, procurement, and supply mechanisms.
The program, like Abbott's, also has initiatives with a focus on general "capacity building" for diagnostic tests, such as helping health systems upgrade laboratory equipment, train personnel, or expand community and personal testing, a spokesperson said. The Geneva, Switzerland-based nonprofit also works directly with countries to find their key diagnostic gaps – some of those issues might involve training needs, technical development – for example, if there is no test that's accurate enough – or market accessibility – if a test is too expensive to be used in low- and middle-income countries.
Meanwhile, the University of Washington's Alliance for Pandemic Preparedness has five functions to help with pandemic prevention and response. Those functions are risk assessment and vulnerability mapping through field studies; big data analytics, and modeling; biomedical innovation, including developing vaccines and diagnostics for pathogens with high pandemic potential; policy and behavioral interventions; capacity development, such as training, technical assistance, and implementation; and communication with governments, the scientific community, at-risk populations, and the general public.
The UW alliance is currently working on a variety of projects for different viruses, including developing mapping tools to characterize the epidemic potential of mosquito-borne viruses in Peru and conducting a survey of mask usage in Washington to help state health officials create educational campaigns for COVID-19.
The US Department of Defense's Defense Advanced Research Projects Agency also has initiatives to encourage the development of diagnostic testing for pandemic preparedness. The Epigenetic Characterization and Observation Program was launched in 2018 to support the development of a point-of-care platform analyzing epigenetic fingerprints to provide a map of someone's exposure to infectious diseases. The Detect It with Gene Editing Technologies program launched last year to enable the development of commercialization of a test using gene editing technology to detect and differentiate among 1,000 pathogens at once from a single sample.
Cloherty said most of the other programs he's seen aren't as broad or able to rapidly create diagnostic tests as quickly as Abbott's coalition. He noted, however, that the company doesn't mind working with the other organizations that have slightly different approaches to stop another pandemic in its tracks.
"We don't want to relive history," Cloherty said.
This story first appeared in our sister publication, 360Dx, which provides in-depth coverage of in vitro diagnostics and the clinical lab market.