NAVIGATION

The Future of Pathology: Going Digital

BY Richard Morroney. February 24, 2015

Pathology intersects with us throughout our lives and also throughout the healthcare delivery system. Clinicians depend on pathologists to screen for diseases like cancer, diagnose illnesses, monitor disease progression and manage therapies1. The application of digital technology in pathology has the potential to transform this previously analog practice as pathologists deliver information and services via digital pathways, i.e., pathology going digital.

Digital Pathology Market

With more than 33 companies worldwide providing digital pathology hardware, software and services, the global digital pathology market is estimated to reach approximately $4.5 billion by 2018. North America dominates this market followed by Europe and Asia2. The Asian market is expected to have the highest growth over the next several years due to an increased awareness of the many potential benefits and the promotion of digital pathology by the Ministries of Health in Asia to improve the quality of cancer diagnosis. Successful programs such as NHS England’s National Pathology Programme’s, Digital First: Clinical Transformation through Pathology Innovation will help to drive adoption of this evolutionary technology.

Innovations in Digital Pathology

Some examples of the use of digital technology and innovation in pathology include:

  • Transforming infrastructure in the area of lab-to-lab communications through direct interfaces with Laboratory Information Management Systems (LIMS) and Laboratory Information Systems (LIS)
  • Providing virtual pathology services at remote sites and facilitating consultations and second opinions
  • Integrating the management of laboratory test results across multi-site labs using different lab information systems, e.g., hematology, immunology, microbiology, cytology and biochemistry. Consolidation through system integration can result in increased efficiency in processing data and supporting the function of multi-disciplinary teams
  • Sharing information to improve patient care such as patient electronic health records and facilitating consultations and referrals
  • Supporting patient self-management, i.e., helping patients with long-term conditions to self-manage their disorders
  • Data mining to obtain business intelligence to better understand pathology processes and then using the derived information to improve pathology services and patient outcomes
  • End-to-end sample management with automated sample identification to better control the collection and transport of samples to laboratories from surgeries and hospital clinics
  • Quantitative and automated image analysis and detection to provide risk-based case prioritization and identification of areas of interest
  • Use in education, training and for presenting cases at tumor boards

Overall benefits of digital pathology can include improvements in service delivery, patient safety and communications, as well as reduced error rates, lower costs, and better and more efficient use of data.

Pathology in the near future will provide digitally-enabled services as the norm to:

  • Provide primary diagnosis of disease
  • Facilitate personalized medicine where therapies are tailored to the individual
  • Extract and analyze data to understand the links between tests and treatments, and to maximize outcomes
  • Help pathologists access prior data and data from a spectrum of different data sites quickly and easily
  • Provide pathologists with a complete view of patients’ health and care
  • Provide an optimized delivery structure by removing geographical boundaries and limitations
  • Empower people to manage their own health through access to electronic health records
  • Enable pathologists to interact more easily with patients directly

Barriers to Adoption

While the potential benefits can be significant, there are questions and concerns about the technology that pose barriers to the adoption of whole slide imaging (WSI). Technical concerns pertaining to digital slide scanning technology, e.g., the ability to scan slides at high magnification and multiple focal planes (the z-axis), image quality, image access speeds and computer hardware limitations for processing and storing extremely large image files will be solved.

Of greater concern are the regulatory issues3: How will regulation be applied to care models in which components of WSI are purchased and operated by different entities (e.g., image capture in one facility, image hosting and manipulation in a second and interpretation in a third facility)?

Will regulatory approval of WSI cover all types of diagnostic work, or will some tissue types, disciplines, analyses or diagnostic entities be excluded? How should WSI be validated? How much data and what types?

There are many issues to consider in the validation of WSI for primary diagnostic application including:

  • Separating the device from the practitioner
  • Pathologist experience (in practice and with the device)
  • Washout and validation setting for concordance studies
  • Types of data generated
  • Measuring accuracy
  • Measuring bias
  • Measuring precision (intra-rater, inter-rater and inter-instrument)
  • Sample size
  • Generalizability of the findings

There has been much progress to date, with regulatory pathways in Canada and EU member states now open for primary diagnosis of whole slide images (WSI). However, regulatory barriers remain in the U.S. market. The FDA regulates WSI systems as Class III high-risk devices. Their position has slowed adoption of this technology, however, recent clearances for scoring of digital images of manually selected regions of interest of immunohistochemically stained slides represent a small step closer to adoption.

Other market-related questions pertaining to adoption of the technology exist, such as: What are the key drivers to adoption of digital pathology? What are the economic models? And who are the decision makers? These questions will surely be answered in time.

Conclusion

Clearly, given the current progress with the regulatory and technical issues, digital technology will transform healthcare and the future delivery of pathology services thus enabling stakeholders to reap the many potential benefits that digital pathology has to offer.

References

  1. NHS England, National Pathology Programme, “Digital First: Clinical Transformation through Pathology Innovation” (2014). http://www.england.nhs.uk/wp-content/uploads/2014/02/pathol-dig-first.pdf. Accessed February 18, 2015.
  2. Armstrong-Smith I. “Facing the Digital Future of Pathology.” The Pathologist.com website. October 3, 2014. https://thepathologist.com/issues/0114/facing-the-digital-future-of-pathology. Accessed February 17, 2015.
  3. Pantanowitz L, Valenstein PN, Evans AJ, Kaplan KJ, Pfeifer JD, Wilbur DC, Collins LC, Colgan TJ. Review of the current state of whole slide imaging in pathology. J Pathol Inform 2011;2:36.

 

Recent posts

Richard Morroney

Richard Morroney, RAC, CQA, is responsible for ensuring global regulatory compliance for Inspirata’s solution offerings. He has more than 20 years of experience in manufacturing operations, internat... Learn More