Industry experts weigh in on how clinical diagnostics will likely evolve 10 years out from the declaration of a worldwide COVID pandemic in 2020.
By Chris Wolski
Summary:
Industry experts predict clinical diagnostics will continue evolving in the wake of COVID with automation, AI, and decentralized testing.
Key takeaways:
- AI and automation will enhance diagnostic speed, accuracy, and data integration.
- Point-of-care and at-home testing will expand accessibility and efficiency.
- Next-generation sequencing and digital pathology will drive innovation in disease surveillance and patient care.
Industry experts weighed in about the lessons learned from the COVID-19 pandemic. But CLP also asked them to look ahead and give a glimpse of how clinical diagnostics will continue to evolve in the next 10 or more years after the March 15, 2020, declaration of a global pandemic.
Their answers reflect growing trends in the industry as a whole—including the widespread implementation of automation and artificial intelligence—and unique opportunities that could also emerge as the industry evolves over the next five years.
Responses have been edited for length and clarity.
John Osiecki, Vice President Medical Affairs, North America, bioMérieux
Access to real-time data and information management systems will be critical for efficient operations. Test result management, data integration between instruments and third-party applications, sample tracking, automated workflow management, quality control monitoring, and advanced reporting and analytics are just a few of the many features that will become routine for the laboratory of the future.
We will continue to see an emphasis on understanding global trends and surveillance of circulating pathogens.
Next Generation Sequencing solutions will continue to be an area of focus for infectious disease diagnostics and expect we will see these technologies move from the research space to clinical applications. Tremendous progress will be made to simplify protocols, improve ease of use, reduce turnaround times, simplify interpretation, and reduce cost.
Implementation of machine learning and artificial intelligence tools will likely become routine in the clinical diagnostic space. These technologies hold great promise for improving accuracy and speed in diagnosis, providing personalized decision support when navigating care pathways, and lowering costs through elevated efficiency.
Adoption of CLIA waived point of care syndromic molecular testing is likely to be common in decentralized patient care settings
Jennifer Schneiders, PhD, president, Diagnostic Solutions for Hologic
The next five years will likely bring more personalized diagnostics and integrated digital health solutions. artificial intelligence (AI) and machine learning will play a pivotal role in evaluating sample data, while collaboration across geographic regions and industries will drive innovation in addressing global health challenges.
We see the integration of AI tools into clinical practice as a critical step to help move the fields of pathology and cytology forward.
Elizabeth Marlowe, PhD, Executive Scientific Director at Quest Diagnostics.
I have witnessed several exciting developments in the field over the past few years. Automation and the digitalization of the health system has been a significant advancement for the clinical laboratory. Automated systems can now perform many of the tasks that were previously done manually. Automation frees up critical laboratory staff to focus on more complex tasks, such as interpreting results, which is further enhanced with the digitalization and application of AI to help sort and group the results for the technologists.
Next-generation sequencing (NGS) has also been a game-changer, allowing us to identify and analyze pathogens more comprehensively and efficiently. NGS is a powerful new technology that can be used to sequence DNA and RNA much faster than traditional methods. This is revolutionizing the way we track, diagnose, and treat infectious diseases. For example, NGS has been used in our laboratory to track SARS-CoV-2 variants and monitor for the emergence of new strains of the virus.
The integration of AI in infectious disease research and diagnostics will allow for greater focus. As automation and machine learning usage increases, so does the laboratory’s ability to analyze and integrate data. Through data integration, we gain the ability to identify early warnings and respond to potential threats soon enough to possibly prevent them from becoming pandemics. Data integration will also allow for more informed decision making, improvements in workflow and smaller equity care gaps, ultimately leading to higher quality care.
Rachele Moore, DBA, MBA, MLS (ASCP)cm, executive director of Laboratory Services for the Aultman Health System
In the next five years, the clinical diagnostic landscape is expected to undergo significant transformations driven by technological advancements and changing healthcare needs. Here are some key trends and developments anticipated in this field:
- Increased Use of AI and Machine Learning: Artificial intelligence and machine learning are poised to play a crucial role in diagnostics, aiding in the interpretation of complex data such as imaging and genomics. This will enhance diagnostic accuracy, speed, and personalization of treatments.
- Expansion of Point-of-Care Testing: There will be a rise in portable and easy-to-use diagnostic devices that allow for real-time testing at the bedside or even at home. This could improve access to testing and reduce the time for diagnosis, leading to more timely treatments.
- Telemedicine and Remote Monitoring: The integration of diagnostics with telehealth platforms will support remote consultations and continuous health monitoring. Patients can perform tests at home and share results with healthcare providers, enhancing accessibility and convenience.
- Enhanced Data Integration and Interoperability: Improved systems for data integration and sharing across platforms will facilitate a more holistic view of patient health. This can lead to better-informed decisions and coordinated care among healthcare providers.
Overall, the evolution of the clinical diagnostics landscape over the next five years will focus on leveraging technology to enhance precision, accessibility, and personalization in healthcare, ultimately leading to better patient outcomes and more efficient healthcare systems.
Nathan Patton, VP Marketing, Near Patient Care, Roche Diagnostics and head of Roche (COVID-19) Pandemic Response Office
Decentralized testing will bring tests closer to the patient, increasing speed, access, diagnosis, and treatment while decreasing the incidence of transmission.
The COVID pandemic opened our eyes to the value and acceptance of self-healthcare. Diagnostic companies must be committed to delivering solutions for at-home testing, where timely screening is crucial, and reducing barriers for those wishing to avoid uncomfortable appointments with a healthcare professional.
Ronald A. Blum, PhD, vice president of Science & Technology at OmniPathology
I believe certain trends will continue, including the further adoption of automation to address the labor shortage, demand for rapid turnaround time, and enhanced quality and accuracy. Automation in accessioning, processing, workflow, analysis and results will continue to play an increasingly important role in lab diagnostics.
In conjunction with automation will be the integration of AI, to enhance decision making, and provide numerous options for solutions to complex problems.
Consolidation of laboratories and institutions will continue in the pursuit of future growth and more profitable testing. Digital pathology, which became essential during COVID, will continue to expand with wider adoption, and reimbursement coverage. AI will play an integral part in the adoption process and lead to greater access to quality care.
The FDA’s LDT rule will likely be amended to allow for the innovation and rapid implementation of new technologies and assays to improve patient care. A move toward a more balanced regulatory environment will help encourage innovation and investment in the lab industry. A streamlined regulatory pathway will shorten time to market and should also reduce costs.
I believe we will continue to see an increase in more remote monitoring of patients and in-home collection and testing.
Nothing Written in Stone
While some of these trends are already becoming reality, nothing is written in stone. A revolutionary change in technology, a shift in the public or political winds, or the emergence of a wholly new kind of pathogen requiring a new clinical approach, could shift any of these predictions for the future.
What is clear: The industry will and expects to change—and we all need to be ready for it.
Chris Wolski is chief editor of CLP.
