Digital pathology techniques were developed more than a decade ago and have unquestionably enhanced digital image sharing among collaborating laboratories and pathologists. When compared to the early global adoption of the technology within the research and pharmaceutical sectors, the uptake of digital platforms within routine, clinical pathology has been somewhat measured. Traditional tissue pathology procedures and protocols have generally changed little in the last 100 years and this has been one factor contributing to the reluctance of many pathologists to embrace the new digital pathology platforms. With the onset of the COVID-19 pandemic however, the value of digital pathology and ‘pathology at a distance’, is becoming increasingly recognized. Could COVID-19 be the catalyst that finally leads us toward full adoption of digital techniques in the routine pathology laboratory?
The ardent need for digital pathology amidst the COVID-19 pandemic
Undoubtedly, the COVID-19 pandemic has—in one way or another—drastically transformed the way of life for many people around the world. The pandemic has also imposed significant challenges to healthcare systems, overwhelming healthcare workers and crippling medical operations worldwide. Although most non-essential healthcare services have all but ceased, since the onset of the pandemic, digital pathology technologies have expanded rapidly.
Several driving factors have contributed to the rapid clinical adoption of digital pathology during the COVID-19 pandemic. First and foremost, many pathologists are required to work from home due to stay-at-home orders and physical distancing guidelines. Digital pathology allows pathologists to continue working from home without compromising patient care. The ability of pathologists to work remotely minimizes the risk of COVID-19 exposure and prevents the further spread of the virus within high-risk communities.1
With hospitals preparing to resume elective surgeries after COVID-19, the number of pathology cases is expected to rise in the next year. This possible increase in the volume of images to be processed and analyzed raises the need for automated and robust image analysis technologies. Digital pathology offers automated tools to accurately and rapidly analyze large volumes of pathology images. The high workload and operational efficiencies of digital pathology technologies significantly increase the number of cases evaluated by each pathologist.2
How can digital pathology facilitate disease diagnosis during the COVID-19 pandemic?
Pathology forms the cornerstone of disease diagnosis and clinical decision making. In cancer studies, in particular, tissue morphology alongside the expression of certain molecular biomarkers provides information critical for accurate diagnosis. In turn, the treatment plan is decided based upon the precise type and stage of cancer. Hence, accurate pathological evaluation and disease diagnosis are key to treatment success.3,4
Digital pathology platforms allow pathologists to view, analyze, share, and annotate digital slides from the comfort—and safety—of their homes. By facilitating remote pathological image analysis, digital pathology enables remote disease diagnosis during this public health crisis. Therefore, digital pathology helps improve treatment outcomes by minimizing delays in treatment initiation during the pandemic.1
In a recent validation study, 12 pathologists from the Warren Alpert Center for Digital and Computational Pathology at Memorial Sloan Kettering Center evaluated more than 1,100 digital slides from 108 patients using their computers at home. Subsequently, pathologists evaluated the same slides in the lab using traditional pathology procedures. The study has shown that pathological evaluation from home using digital pathology platforms was operationally feasible and did not compromise the accuracy of diagnosis. Notably, major diagnostic equivalency between evaluations of digital and glass slides was 100%, and overall concordance was 98.8%.5 This validation study was published in Model Pathology, and the findings of the study were critical to the regulatory approval of this first “home” digital pathology system.
Impact of COVID-19 on the clinical implementation of digital pathology
Due to the ever-increasing need for automated and remote clinical image analysis platforms imposed by the pandemic, regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have relaxed some of the regulations regarding the approval of digital pathology-related technologies.6 These amendments to the approval guidelines are aimed at accelerating the approval of digital pathology platforms to enable pathologists to continue working remotely during the pandemic.
Similarly, government bodies that regulate diagnostic laboratories have relaxed their guidelines regarding the use of digital pathology-related technologies to allow pathologists to use digital pathology platforms from home.
Popular digital pathology platforms during the COVID-19 pandemic
There is a wide variety of digital pathology tools that enable remote whole-slide image analysis and sharing. Although all of the following digital pathology platforms have gained increasing popularity during the pandemic, they all have their specific advantages.
- Knowledge in Knowledge out: KiKo. The social platform was created in 2020 by Jonhan Ho, Assistant Professor of Dermatology and Pathology at the University of Pittsburgh Medical Center. The platform allows pathologists to share whole-slide images in real-time. The platform recently hosted global digital dermatopathology grand rounds, during which pathologists from around the world shared cases and their clinical knowledge and tips.
- PathcoreFlow™. This platform offers a robust workflow solution for pathologists in both research and clinical laboratories. It is entirely browser-based and accessible from any device without the need for extensions or plugins. The platform allows users to organize, analyze, annotate, and share digital whole-slide images at any time and from anywhere.
- PathcoreLive™. The software enables remote, real-time, browser-based scanning and viewing of whole slides, allowing remote consultations. Furthermore, the platform offers tools to create virtual and interactive classrooms, as well as the broadcast of tumor boards for remote colleagues.
- Concentriq® Dx (PROSCIA). This system allows pathologists to securely review and analyze whole-slide images remotely on any device using an Internet browser. The software works with images acquired on any of the most commonly used scanners (e.g., Leica, 3DHISTECH, and Hamamatsu). Concentriq® Dx has been approved for remote clinical use in the US during the COVID-19 pandemic.
Perspectives
The COVID-19 pandemic has substantially changed virtually every aspect of our lives and has imposed significant challenges to healthcare systems worldwide. However, telemedicine platforms and digital pathology technologies have blossomed during these challenging times.
The guidelines regulating the use and approval of digital pathologies technologies have been amended in many countries in the midst of the COVID-19, significantly accelerating the integration of digital pathology into clinical practice and potentially curving the mindset of pathologists to the advantages of digital pathology.
Given the many benefits of using digital pathology over traditional pathology, including high accuracy and speed, the widespread clinical implementation of digital pathology technologies can prove to be a silver lining in this devastating health crisis.
References
1. Browning L, Colling R, Rakha E, et al. Digital pathology and artificial intelligence will be key to supporting clinical and academic cellular pathology through COVID-19 and future crises: The PathLAKE consortium perspective. J Clin Pathol. 2020:1-5. doi:10.1136/jclinpath-2020-206854
2. Browning L, Fryer E, Roskell D, et al. Role of digital pathology in diagnostic histopathology in the response to COVID-19: results from a survey of experience in a UK tertiary referral hospital. J Clin Pathol. 2020:jclinpath-2020-206786. doi:10.1136/jclinpath-2020-206786
3. Improving Cancer Diagnosis and Care: Patient Access to Oncologic Imaging and Pathology Expertise and Technologies: Proceedings of a Workshop. In: National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; National Cancer Policy Forum. Washington (DC); 2018. doi:10.17226/25163
4. Vaidyanathan R, Soon RH, Zhang P, Jiang K, Lim CT. Cancer diagnosis: from tumor to liquid biopsy and beyond. Lab Chip. 2018;19(1):11-34. doi:10.1039/c8lc00684a
5. Hanna MG, Reuter VE, Ardon O, et al. Validation of a digital pathology system including remote review during the COVID-19 pandemic. Mod Pathol. 2020;33(11):2115-2127. doi:10.1038/s41379-020-0601-5
6. Food and Drug Administration. Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID19) Public Health Emergency. Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff. 2020;2019(April):1-8. https://www.fda.gov/media/137307/download.
