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This article is a continuation of a conversation started in the September 2010 print issue.
Cathy Boutin, marketing manager, Cambridge Research & Instrumentation Inc. (CRi)
Gene Cartwright, CEO, Omnyx
Peter Duncan, director, Business Development, Clinical Diagnostics, Definiens
Ole Eichhorn, chief technology officer, Aperio
Michael D. Harris, development director, GlobalMedia Group LLC
Philippe Nore, international business leader, Ventana Medical Systems Inc.
Ajit Singh, PhD, chief executive officer, and Robert Monroe, MD, PhD, chief medical officer, BioImagene (acquired by Ventana Medical Systems Inc., a member of the Roche Group)
What is the industry doing to improve interoperability in digital pathology? What still needs to be done?
Boutin: Little has transpired to improve interoperability in digital pathology. The formation of the Digital Pathology Association has helped, although it will take a higher level of interplay across the entire industry. Key issues that need interoperability, and to some extent, standardization are: 1) image resolution and format should be standardized irrespective of the scanning device and viewing software; 2) viewing systems (e.g., monitors, etc.) should be standardized and/or calibrated to a particular standard; 3) image quality should not change when electronically transferred; 4) hardware/software (irrespective of the vendor) should be interoperable with other lab equipment such as strainers, microtomes, EMR [electronic medical record] systems, data storage systems, billing and reporting systems and data transfer protocols.
Cartwright: Interoperability is a challenge, and if one uses radiology as a guidepost, it took over a decade for interoperability to be effective. It will happen faster in pathology, but we are just beginning. It is critical the source data from existing APLIS systems is available and used to control processes and provide critical patient information to the digital pathology systems. In addition, the DICOM standard will allow systems to share pathology images. Lastly, there is a significant opportunity to flow pathology information to the EMR.
Duncan: If you accept that image analysis is key to utilization of digital pathology in the clinical or translational research setting, many software applications have inherent issues that a pathologist must contend with. As the market grows, things will get sorted out in terms of who provides the best of all worlds (i.e., scanning, analysis, image management, ease of use, ease of workflow integration). But companies are still sorting out what their specific niches are. Ultimately, the market and the science will provide a positive force into improving interoperability in digital pathology.
Eichhorn: The Digital Pathology Association has been formed to foster adoption of digital pathology, and includes promoting standards among its goals. Adoption of standards such as barcoding, HL7 and DICOM Supp 145 by digital pathology vendors will help. Interoperability can take place at many different places within a digital pathology system. Aperio has an open system, which includes numerous Application Program Interfaces (APIs) that enable third-party interfaces. Because they are open and well-documented, these promote interoperability. For example, Aperio has created a common interface for development of image analysis applications. A wide variety of companies have created applications using this interface, and they are interoperable on Aperio's platform.
Harris: Patient records are not always complete. Standards are still being developed and tested. DICOM is not yet a pathology standard. I see a day where any and all patient records, images and database, alike, are stored and shared across the entire hospital network.
Nore: Interoperability will be driven by relationships between digital pathology hardware and software vendors and LIS companies. Industry has also been actively working to craft a supplement to the DICOM medical imaging standard to enable whole slide images to be stored within the standard, which currently does not accommodate such large images; pixel dimensions and object size exceed the maximum values supported.
Drs. Singh and Monroe: The industry is working with DICOM Working Group 26 to establish a standard image format for whole slide images that could be read by systems and platforms from all vendors. This image format has not been finalized at this point.
As a company, BioImagene has developed an image viewer that can read whole slide images of various formats. This viewer is available to all interested pathologists through the PathXchange website, where pathologists can upload cases and view cases of any image format. At this point, most vendors' algorithms are developed to work on images of only a single format. In order to support other image formats, these algorithms must be modified for these image types, which is a time-intensive process.
Having a common image format for whole slide images will allow algorithms to be developed specifically for this format and work on images from various platforms.
Can lab and hospital administrators justify the cost of digital pathology today? If so, how? If not, why not?
Boutin: Yes, in fact digital pathology, if implemented properly, can deliver a return on the investment. Here's how. It a) decreases the turnaround time for diagnosis for hospitals who do not have in-house pathologists or expertise in particular disease areas; second opinions can be made almost instantly; b) eliminates the cost and time to make extra physical slides for second or third opinions; c) eliminates the cost and risk of transportation of fragile glass slides via courier services; d) eliminates time to transport slides; e) eliminates storage costs for archiving slides (versus the digital images that can be backed up and stored on comparatively inexpensive media); f) has the potential to improve the quality of second or third opinions by presenting the same sample to multiple sites rather than having to prepare multiple slides. This can be particularly critical when a tissue anomaly is very small and difficult to section into multiple slides effectively. Digital pathology avoids the issue by distributing the same slide of the same anomaly to multiple sites for review.
Cartwright: Justifying the cost depends on the benefits a hospital receives. Not all digital pathology systems deliver the same level of benefits. The two main quantifiable benefits are efficiency gains and increased revenue. At Omnyx, we have performed time motion studies to measure efficiency gain opportunities as well as worked with organizations to develop business cases for increasing case volumes through outreach. The efficiency gains offered by the Omnyx system can pay for and justify most, if not all, of the purchase. Increased case volumes, consultation through outreach and reimbursement differential for IHC algorithms also add to the quantitative benefit through revenue generation.
Duncan: Absolutely. One way to look at this is to ask: "Could the collective economies of the world have grown to the level they are today without Microsoft Word or the Internet?" The ability to edit and save files, collaborate and even do "spell check" add to enormous efficiency and productivity. When things are in digital format, you can collaborate, analyze, review, sort and recall data in many more ways than in analog format. From a cost and healthcare efficiency viewpoint, we are fast approaching the day when patient records include all digital images and associated patient data for their specific case (pathology, radiology, anatomic, etc.), and this is already in progress at several leading cancer centers. From an accuracy of diagnostics point of view, several studies have shown that digital pathology image analysis provides 20-50% more accuracy than manual, qualitative approaches. This has a major impact on applying the appropriate treatment regimens, whether the diagnostic is being utilized as prognostic or for therapeutic response prediction. From a translational research point of view, digital pathology has enormous promise in helping further understand the biology related to biomarker expression and tissue morphology of complex diseases, both of which are playing a major role in drug development and clinical diagnostics.
Eichhorn: The cost of digital pathology can be justified for a number of applications in hospital labs. Aperio works with customers to analyze and quantify their workflow to enable ROI calculations for common applications to be performed. An increasing number of applications for digital pathology will be cost-justified over time as the value propositions of the new technology become established.
Harris: Absolutely. First, the cost of digital pathology and digital microscopy has come way down in the past few years. That said, being able to share a live view of a HE stain with another pathologist just for a second opinion could save time and in some cases, lives. If a pathologist needs to review an image from home, on the road or from another hospital, the digital archiving is available 24/7. The cost far outweighs poor or late diagnoses. This helps the hospital, the insurance company and most of all, the patient.
Nore: Absolutely. With pathologists' time at a premium and a shortage of pathologists in some parts of the country, digital pathology can streamline the daily workflow of the pathologist and bring significant quantifiable improvements to pathologist efficiencies. Recent studies have found that productivity gains to the pathologist can be 10-20% depending on the type of lab. Efficiencies are gained in case assembly, tumor board preparation, consultations and image retrieval.
Drs. Singh and Monroe: Yes, hospitals can justify the cost by increased efficiencies and improvements in pathology diagnoses. Through use of digital pathology, hospitals can reduce shipping costs associated with consultations and improve turnaround time on cases, which can reduce the length of time that patients' stay in the hospital. Hospitals with immunohistochemistry [IHC] and FISH [fluorescent in situ hybridization] capabilities also benefit financially from the increased reimbursement associated with use of digital pathology and image analysis, which can offset costs of some digital pathology systems, such as those offered by BioImagene, which are available on a pay-per-click basis. Hence, hospitals are not required to make capital expenditures to bring the technology to their pathology departments.
Finally, digital pathology can improve the quality of diagnosis and patient care. In the case of quantification of IHC studies, digital pathology and image analysis improve the accuracy and reproducibility of pathologists' interpretations, leading to better information for oncologists and other clinicians in treatment decisions for patients.
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