Vendors’ Viewpoints

What is pathologists’ biggest concern about digital pathology adoption?

MB: The scarcity of time! Because of increased workloads – including identifying new markers needed for diagnosis – pathologists are short of time to commit to new training and to consider testing a digital solution compared with their current procedure.

Pathologists still need convincing of the benefits of sharing images and the fact that the time needed to view a case from a digital image can be as fast as viewing using a microscope. However, computers are getting faster and networking technology is providing more bandwidth for transferring large image files, so the gap is closing as the pixilation of large images associated with digital pathology is now becoming a thing of the past.

Also, the lack of clear guidance from regulatory authorities about the validity of using digital slides to report cases is an issue. Pathologists are very concerned about their legal position if they misdiagnose a case using a digital slide displayed on a computer screen.

PvR: There are concerns over clinical (regulatory), technology and system integration and financial issues. In general, we hear from customers using our solution for high volume pathology laboratories and integrated pathology networks that digital pathology is important for moving their businesses forward. Most have some experience with digital pathology and know that they need help to make the full shift to digital. High image quality and system performance are a prerequisite for them, so the real discussion is about integration with their existing workflow, connectivity, IT infrastructure and scalability.

OC: Although there are a number of good reasons for adopting digital pathology, there are also obstacles.

Historically, the cost of systems combined with few research papers validating the return on investment (ROI) were a factor preventing implementation. The total-cost-of-ownership can be higher than expected too.

Also, as pathologists tend to be traditionalists and there is limited regulatory approval in some regions of the world, institutions are wary of it. While it makes collaborating quicker, compared with shipping slides or needing a pathologist to travel to different sites, the user experience when viewing slides can be slower than that of a microscope (if wide area networking is limited or if users need training or if they lack familiarity with the system, for example).

What is being done to address the concerns?

MB: There is more exposure to digital images these days, so greater familiarity with the technology is important. New trainee pathologists, for example, are taught how to work with digital images from an early stage of their career; also, there is more interest and use of digital pathology for the EQA (External Quality Assessment) scheme. The tipping point will come when the training norm will be to use digital images and pathologists will progress onto reporting from scans of their routine cases.

There are a number of ongoing tests and trials to show side-by-side comparisons between standard reporting and reporting from a digital image. These tests look at what is limiting the uptake of digital pathology – reporting time, image quality and the effect on workflow. We believe the results of these trials will encourage pathologists to accept that this is the future of pathology.

However, clear guidelines on reporting from a digital image and whether a standard process is required to integrate the workflow are needed. The FDA, EU and others must provide leadership and discuss with slide scanning companies how to optimize the process so that pathologists can benefit fully from this new technology.

PvR: Pathology is very demanding and digitization can provide great benefits if implemented correctly. But we recognize that this differs per lab, so together with the pathologist we define a solution that works for them – whether it be workflow, IT, or finance, for example. Providing the technology is half of the service, the rest is provided in support to ensure that the right steps are taken towards effective digitization.

OC: As an increasing number of institutions adopt digital pathology for routine diagnostics and second opinions (outside the USA), there is documented evidence of diagnostic equivalence with conventional light microscopy. Also, more use of the technology is providing independent and true total-cost-of-ownership evaluations. In addition, improved connectivity coupled with improvements in system throughput and performance provides a better user experience when reviewing digital slides.

The global trend towards big data, cloud-based solutions, reduced costs for server space and storage, and improvements in data security are also helping to reduce the uncertainty felt by some institutions and individuals around digital pathology.  In addition, the clearance of certain digital pathology image analysis systems by the US Food and Drug Administration, combined with its adoption for primary diagnosis in Canada and Europe, is helping to increase overall confidence in, and exposure to, the technology.

Which innovations are most widely adopted? Where is research and development heading?

MB: We have found that there are a large number of pathologists who are willing to use and diagnose from a digital image instead of a microscope, especially with regard to cellular pathology. For instance, it is now possible to scan a section in under one minute and therefore we are moving on from simply accepting the ability to scan and share a whole slide.

We believe that new research and development will improve features such as multi-level scanning of whole slides to replicate the z-axis focus function of a microscope. Also, extended focus imaging will enable us to merge multilevel images together so that a whole section is in focus at every point. This will take us to a point where an image from a slide scanner provides a new perspective that cannot be achieved on a microscope.

Current methods of evaluating slides lead to a degree of observer variation, which can be reduced by using digital pathology. New algorithms are being produced that can extract more information from a whole slide image or multiple slides to provide more numerical data. These improvements should progress patient diagnosis by reducing the number of possible mistakes and decreasing the time for a diagnosis.

PvR: Now, pathologists can interact with a digital image in an intuitive way and they can collaborate with others using this technology. However, innovation in healthcare is not just about technical developments. New ways of working are helping to achieve improved health outcomes in a cost effective way. Digitization, therefore, provides a backdrop for looking at new ways to improve the patient experience.

OC: Digital pathology emerged primarily in the education sector. It was then adopted by researchers. Its ability to capture whole slide scans and automatically analyze them for different phenotypes and expression for high-throughput assessment has been particularly popular in biomarker discovery.

Image sharing and collaboration for a variety of cases is another of the most widely recognized uses of the technology; this is validated by a number of studies across a broad range of providers. The technology is also enabling efficiencies in tumor boards, second opinions, and other applications requiring access to subspecialty expertise, which provides objectively verifiable ROI.

More recently, the use of automated image analysis in a clinical setting, such as a companion diagnostic HER2 assay, enables reproducible and objective stratification of patients into cohorts of likely responses to drug therapies and helps to eliminate inter- and intra-observer interpretation variability.

With increased subspecialization of pathologists, the ability to engage with experts in a given field is greatly enhanced by digital pathology. This is helping with difficult evaluations, streamlining access to the right experts, and ultimately improving turnaround time for decision support to the benefit of researchers, health care providers and patients.

What is your prediction for the role of the pathologist in the next 10 years; how will digital pathology affect the way they work?

MB: Although there has been significant investment into genomic research in recent years, without pathologists helping us to appreciate how those genetic differences affect tissue we will never truly understand disease. So, with advances in personalized medicine we believe that the workload and importance of pathologists will increase.

Digital pathology will enable pathologists and pathology departments to become more efficient. The ability to view images from any location in the world will allow them to be more flexible and to provide specialist or second opinions quickly. In addition, image analysis will allow them to provide responses rapidly and accurately, especially with routine cases, which will give more time for dealing with difficult cases.

PvR: First, there will be an intensified collaboration between pathologists as well as within cross-disciplinary teams. This opens up new opportunities for pathology labs, for example, to offer their expertise to regions beyond their current scope, where experienced or specialized pathologists are scarce.  Second, the role of the pathologist in taking clinical decisions will increase based on their central role in extracting more data from tissue.  Digital pathology will complement the increasing need to develop quantitative data sets to help develop predictive algorithms for personalizing cancer care.

OC: With the consolidation of healthcare resources, pathologists are working in distributed environments, often separated from colleagues and laboratory facilities, so digital pathology will help to improve efficiency in sharing slides and cases. Also, the implementation of electronic health records is optimized by digital images.

In addition, early detection and screening programs, combined with minimally invasive biopsy and surgery, often results in less tissue to analyze. This, coupled with the emergence of new biomarkers and increased trend towards companion diagnostics, is driving the use of multiplexing several markers on a single sample, which is best interpreted using automated image analysis.

In the end, digital pathology will lead to greater efficiencies in laboratory workflow, provide decision support tools, and transform the interaction between oncologists, pathologists and patients, as well as researchers, instructors and students. In 10 years’ time, we predict that, digital pathology will be known simply as “pathology.”