January 7, 2021 | Pathogen surveillance tops the trends leaders from the Diagnostics World vendor community predict for 2021. Following a year where diagnostics needs took us a bit by surprise, broad pathogen surveillance will be key. “2021 will bring an increased awareness about the need for this approach to discover and mitigate future pandemics,” said Lauge Farnaes of IDbyDNA. “In order to accomplish this large task, surveillance strategies and tactics will need to be built into our healthcare system and will be required to standardize pathogen testing.”
This is a change, says PerkinElmer’s Arvind Kothandaraman, but, “COVID-19 necessitated this shift, and labs have realized that they must be equipped with life science and diagnostic tools to better manage the spread of infectious diseases now and in the future.”
Yet as we have been assailed by a virus in 2020, antibiotic stewardship will also be essential in 2021. “As a virus, SARS-CoV-2 does not respond to antibiotics, but COVID-19 patients often present with respiratory symptoms associated with pneumonia and are therefore prescribed broad spectrum antibiotics,” explained Alon Singer with HelixBind. In fact, Oliver Schacht of OpGen calls antimicrobial resistance, “a pandemic underlying the COVID-19 pandemic.”
Surveillance and stewardship depend on data management and buy-in from regulatory bodies—the same groups that have had to make big changes to approvals this year. “The FDA, CDC and other regulatory bodies will put new, more progressive systems in place as a result of the pandemic,” GoodCell’s Brad Hamilton predicted. And Kris Fitzgerald with NTT DATA Services says, “Creating one centralized data management, analytics, and governance repository for government and healthcare professionals is critical to truly defeating COVID-19.”
Within the Diagnostics World vendor community, leaders have been working hard to synthesize what 2020 brought us and apply those learnings to 2021. Here are the full trends and predictions including additional forecasts for telehealth and home diagnostics, machine learning-based triage, omics for diagnostics, and supply chain reliability. –the Editors
Alon Singer, CEO and founder, HelixBind
Antimicrobial resistance will continue to grow. According to the CDC, each year in the U.S., at least 2.8 million people are infected with antibiotic-resistant bacteria or fungi, and more than 35,000 people die as a result. Aggressive use of antibiotics in suspected COVID-19 cases will likely drive an increase in resistant bacteria in both the near and long term. As a virus, SARS-CoV-2 does not respond to antibiotics, but COVID-19 patients often present with respiratory symptoms associated with pneumonia and are therefore prescribed broad spectrum antibiotics.
Antibiotic Stewardship programs will continue to expand. As of 2017, less than half of all US-based hospitals had active antimicrobial stewardship programs in place. The CDC and CMS have made significant efforts to encourage adoption of these programs in both hospitals and nursing homes. Antimicrobial stewardship programs help reduce the unnecessary use of antimicrobials, thus reducing side-effects, lowering costs, and slowing the growth of antimicrobial resistance. Most larger hospitals have implemented such programs and the focus is on smaller, less-resourced sites. Potential solutions include pooling of resources among hospitals, utilizing the resources of a larger health care system if feasible, taking advantage of state health department resources, and use of telehealth activities.
Use of rapid testing to quickly identify infectious agents will expand. Driven by COVID-19, there will be a growing acceptance of rapid tests and their importance—not only for COVID-19 itself but other diseases, such as the flu. I expect that infrastructure and policies, such as reimbursements, put in place will be leveraged to speed adoption of these diagnostics and improve patient care.
Increased interest, awareness, and funding for combatting infectious diseases. The enormous financial, social, and personal cost of the pandemic have and will lead to more investments in prevention, testing and treatment plans for infectious disease. We don’t want to have to face a scenario like this unprepared ever again.
Brad Hamilton, Founder and Chief Science Officer,GoodCell
The FDA, CDC and other regulatory bodies will put new, more progressive systems in place as a result of the pandemic. 2020 demonstrated what’s truly possible when science and technology come together. As just one example, a vaccine that could have taken seven to 10 years to develop is anticipated in less than one. Regulatory agencies will have to reassess their processes for approvals and compliance to keep pace with the advancement of medical and scientific breakthroughs, as well as the speed in which health challenges can spread globally. We’re likely to see the FDA, CDC, and other regulatory bodies putting new, more progressive systems in place to support the more rapid deployment of vaccines and therapeutics.
Integration of telehealth into the collection and testing of biological samples from home. Before the pandemic, many viewed telehealth and at-home sample collections as less-validated ways to receive samples. However, the pandemic accelerated development of technologies and the integration of telehealth into the collection and testing of biological samples from home. We can anticipate seeing even greater innovation in at-home test collection, and further guidance from the FDA on how best to regulate these processes, as more people embrace the safety and opportunities afforded by virtual care. This could prove critical to adding greater diversity of drug trials and improving healthcare access in underserved communities.”
Kris Fitzgerald, CTO, NTT DATA Services
Creating one centralized data management, analytics, and governance repository for government and healthcare professionals is critical to truly defeating COVID-19. Healthcare workers and pharmaceutical companies have been in the trenches the past several months treating COVID-19 patients and conducting research to develop a vaccine, and the technology industry has an obligation to contribute to this cause, as well. COVID-19-specific data is being generated at incredibly high volumes and speeds—from symptoms, to contact tracing, infection and recovery rates, and more. However, the governance around this data is severely lacking. By creating one centralized data management, analytics, and governance repository, government officials and healthcare professionals overseeing distribution of the vaccine can better analyze the data available to them to generate more accurate real-time decisions. This allows them to move swiftly and efficiently on in-the-moment insights, such as geographical case spikes or rural areas with a lack of resources to properly store the vaccine, to increase agility and respond to constantly changing consumer and supply chain needs. Real-time, trustworthy and transparent data management, as well as consulting from technology and data experts, has never been more important. As we learn more about the virus and how to prevent it, data will be the key that unlocks critical information around flattening the curve and efficiently and strategically distributing the vaccine.
Don Woodlock, VP Healthcare of Solutions, InterSystems
Machine learning-based triage: Health systems have used simple risk scoring systems with a few variables forever as a way to find patients that need immediate attention, higher acuity resources and pathways, etc. Machine learning will increasingly be used in many more parts of the patient’s chart to make smarter decisions. For example, Northwell’s ML system identifies patients who need to be woken up to take their vitals versus patients who are safe enough to just sleep through the night.
Klaus Lindpaintner, Chief Medical Officer and Chief Scientific Officer, InterVenn BioSciences
What we are currently witnessing is really an explosion in the application of omics to clinical diagnostics to predictive tools that are medically applicable driven by some very significant progress in both wet-lab technology, specifically, for instance, with regard to mass spectrometry vitrectomy, that has really propelled proteomics forward from where we used to just look at genomics and all that combined now with the amazing power of artificial intelligence that allows us to really look at the data and process the amazing amount of data that are being generated in a way that allows it all to be scalable and ultimately applicable to clinical practice and to the benefit of the patient.
What happened in 2020 is that the pandemic has clearly highlighted the importance of biotechnology, the importance of thinking very actively about how we can improve medicine as rapidly as possible. And so that has really fertilized the way we have been thinking about this and has energized the field in a dramatic fashion as we have all witnessed over the last year. What we’ve been witnessing is the advent of what people refer to as liquid biopsies, mainly the ability to really understand and treat and monitor cancer-based on blood samples rather than what used to be necessarily tissue samples which are much more invasive and difficult to get. And there, we have really made a fairly important step advance in 2020, as we’re moving into 2021, with more and more laboratories, more and more companies focusing on this, a lot of them looking at DNA-based markers but increasingly also at protein-based markets.
AI trends allow us to mine very, very large sets of real-world clinical data, to extract information that is otherwise very, very difficult to get at. And that clearly fertilizes clinical research and ultimately allows us to device the testing algorithms as well as, down the line, novel therapeutics that heretofore just were not possible. Just think about how these tools can recognize faces today, that’s exactly how they’re now being geared up to recognize molecular structures in a way that is vastly more powerful and vastly faster than was ever possible before. So, the advance of artificial intelligence, machine learning, neural networks given the complexity of biology is absolutely essential for us to move forward at an increasing pace.
Lauge Farnaes, Head of Medical Affairs, IDbyDNA
Broader Testing for Broader Pathogens: As the vaccine is deployed, it will be important that broader testing for respiratory illnesses is also leveraged, so that health professionals, clinicians and the global health community can identify pathogens that are returning, and can track how the vaccine is fighting all pathogens, and how that is impacting the evolution of COVID-19.
Insights into Secondary Infections: It will be critical to understand secondary infections as a key driver of morbidity and mortality, and specifically how they Secondary they intersect with COVID-19. As we gain a deeper understanding of co-infections, the world will be able to better manage the treatment of the virus and in turn, can support the available bed space in hospitals.
Stepped-Up Surveillance: As we’ve seen this year, pathogen surveillance is as important as testing and IDbyDNA believes 2021 will bring an increased awareness about the need for this approach to discover and mitigate future pandemics. In order to accomplish this large task, surveillance strategies and tactics will need to be built into our healthcare system and will be required to standardize pathogen testing. The key takeaway from 2020 should be the importance of Investing in preparedness—including building a comprehensive database and techniques that integrate reservoir data from agriculture and allow the community to better respond to new threats.
Rapid Resistance Detection: Beyond identifying pathogens, it should also be a priority to deliver more comprehensive identification of antimicrobial resistance markers. With the help of sequencing-based AMR profiles, this approach will allow providers to help ensure patients are getting on the proper antibiotics quicker, thereby getting patients out of the hospital to better manage the healthcare system’s finite bed capacity.
Large-Volume Testing with Smaller Teams: In 2021, it will be more important than ever that labs can manage large-volume testing with a smaller workforce. In an effort to safeguard critical workforces, testing that can be completed with a reduced number of personnel will be vital and can be accomplished as more labs adopt digitization and robotics to support new testing methods.
Oliver Schacht, CEO, OpGen
Heading into 2021, it’s crucial for healthcare workers, researchers and professionals to recognize that AMR is a pandemic underlying the COVID-19 pandemic. During the COVID-19 crisis, use of antibiotics including azithromycin and ceftriaxone spiked, and up to 70% of patients (maybe even higher) received antibiotics despite the fact that COVID-19 is a virus. But this empiric antibiotic use was largely driven by the uncertainties about possible bacterial co-infections. COVID-19 patients, and especially the severe cases with prolonged hospitalization, can and do develop secondary bacterial infections, such as pneumonia, and it is imperative that the correct diagnosis is made rapidly and accurately in order to guide appropriate antibiotic treatment decisions.
Broader AMR diagnostic panels must be adopted in more healthcare facilities to empower providers with faster, more accurate patient and pathogen information. This is especially crucial when fighting respiratory diseases like COVID-19, which can present similarly to other infectious diseases and which open patients up to secondary infections during the treatment course. In addition to rapid CoV-2 diagnosis, healthcare workers must realize that detecting life threatening bacterial co-infections and their AMR patterns is also critical in making sure the right patient gets the right antibiotic. If left undetected or mistreated, co-infections can spread rapidly, particularly in ICUs and long-term care facilities where patients are most vulnerable.
Healthcare facilities need to take a precision medicine approach to treating drug-resistance and infectious diseases. This means investing in and relying on rapid molecular diagnostics rather than empiric guesswork. Expanding access to rapid, molecular diagnostic panels will bring more accurate diagnostic results and treatment insights into the hands of doctors faster, thereby reducing overuse of broad-spectrum antibiotics and encouraging antibiotic stewardship on a broader scale.
Mark Dobbs, global healthcare alliances, enterprise imaging, Pure Storage
The imaging and AI connection is becoming inseparable. COVID-19 has accelerated the need for enterprise imaging and telehealth via remote access to imaging and reports. It also shines a spotlight on the need for expanded use of AI and machine learning in imaging, with the dual goals of improved diagnoses and greater clinician wellness and job satisfaction. It can also have a positive impact on an institution’s financial health. Industry studies estimate that 37 percent of a hospital’s revenue is derived from imaging. More than ever, facilities need to optimize the use of their imaging facilities to protect the bottom line—and AI is playing an important role.
Jeremy Simon, lead, OEM Commercial activities, and Jerry Carlson, Product Support Manager, Dunlee
Amplified Interest in Cost-Effective Equipment: In response to the COVID-19 pandemic, many radiology departments shifted activity to diagnose and assess acute illnesses. This has led to a demand for cost-effective systems and components to assist with this work. Value and performance segment equipment will allow preparedness while respecting budgets.
Clinicians Want Supply Reliability: Uptime is of the upmost importance to radiology departments. Due to the supply chain challenges that were experienced earlier this year, they want to know that they can rely on their imaging equipment even before they will need it. Ensuring hospitals and their service providers are well-stocked with imaging components is critical heading into 2021.
AI-Assisted Algorithms for CT Scans: Artificial intelligence will play a more involved role in improving both diagnoses and department workflow. For example, CMS is already supporting the use of AI software that alerts a neurosurgeon of evidence on a CT scan of blood clots in a patient’s brain. This type of AI-driven clinical support will be especially useful when dealing with increased workloads.
Arvind Kothandaraman, PerkinElmer
Lab agility: A major takeaway from COVID-19 has been that every second matters when it comes to a response. In order to be more nimble and agile, labs require tools with high levels of sensitivity and reliability in order to detect disease, develop therapeutics and discover preventive measures that can be taken before there is an opportunity for a surge to begin. Early detection and diagnostics are vital for labs as screening becomes the new normal.
Shift to Surveillance: We will see a shift toward molecular testing and surveillance in general over the next year or two. COVID-19 necessitated this shift, and labs have realized that they must be equipped with life science and diagnostic tools to better manage the spread of infectious diseases now and in the future. While we hope to never experience a pandemic of this magnitude again, it is in our best interest for labs to proactively conduct surveillance to better manage the potential risk.