Digital Pathology Issues Will be Sorted Over Time

Introduction

Digital Pathology (DP) is defined as a dynamic, image-based environment that enables the acquisition, management and interpretation of pathology information generated from a digitized glass slide [1]. It can be further subdivided into virtual microscopy and telepathology. Virtual microscopy deals with the scanning, storing, transmitting and posting pathological slides on one or more computer systems. Telepathology deals with the analysis of the slides by one or more pathologists who are not physically present at the site of the glass slide. Digital pathology is a rapidly growing field within InVitro Diagnostics (IVD).

Advantage of Digital Pathology

DP attacks the central challenge facing pathology departments over the decades – the physical coupling of pathologists and the slides which has stalled the increase in productivity of pathologists by retarding scalability. Digital pathology creates an environment where pathologists can access whole slide images whenever and wherever they choose, either through a computer system or even on a smart phone. It allows them to consult multiple senior pathologists at the same time and get their opinions without physically transporting the slide. It creates a vista of opportunities for educational and research institutes. Images can be stored for decades without loss of quality. It also opens up avenues of consistency in slide scoring by removing ambiguity associated with human eye.

DP has the potential to dramatically increase throughput, reduce expenses by removing slide storage costs, improve productivity and efficiency, reduce manual error, intelligently assist pathologists, surgeons and hospital administrators to identify and rectify bottlenecks in laboratory workflow, improve timely treatment decisions and ensure better patient care.

Market

According to GE Healthcare, the current market size of DP is estimated to be around $150 million. It is expected to grow to $2 billion by 2020 [2]. In the US, approximately 1.5 billion histopathological slides are investigated manually each year [3]. Currently, digital pathology is used predominantly by pharmaceutical companies (for toxicological studies), veterinary pathologists, and teaching institutes.

There is rapid growth in the development of digital pathology technology. Current state of the art digital pathology systems seamlessly integrate scanners to the consultant’s workstation and also to hospital servers and laboratory information systems. The services offered by the commercial products include rapid, high-resolution sample scanners, a hosting service to store the digital slides, and software to help read slides on a computer monitor. Although there are minor differences, the throughput of currently available slide scanners is around 40 slides per hour. The cost of digital pathology systems can vary from around $30,000 for desktop-sized slide scanners [4], to upwards of $1 million for a comprehensive digital pathology system complete with a few state-of-the-art scanners, processors, servers, networking infrastructure, computers and at least two high-resolution 20-inch monitors (similar to monitors used in radiology).

Pain Points

For increasing the adoption of digital pathology systems, a number of pain points need to be addressed. A look at the results of the survey conducted by Laboratory Economics makes it clear that expense is the most important barrier for widespread adoption of digital pathology [5]. While absence of clearance from the FDA, and its decision to classify digital pathology systems for primary diagnoses as class 3 medical devices has acted as a big damper, the bigger problem is the cost of the systems. More than half the respondents felt that DP solutions are too costly. While the costs will come down when economies of scale kick in, the OEMs should proactively look at cost reduction as a fundamental strategy to improve their business.

One strategy is to use cloud-based technologies. This will reduce the cost of storage and alleviate the need for a standalone dedicated server and network systems. A Houston-based software company, Smart Imaging Technologies, and its Simagis Live solution lets the user upload, store, share and retrieve whole slide images on the cloud [6].

Another reason for the high cost of DP systems is the cost of the scanner. The price tag may be attainable for a large hospital with a sizeable budget and a dedicated IT staff. However, a large number of pathology labs are small setups with minimal staffing. They have no capital budgets or IT support. It is impossible for them to splurge on large IT investments or a technical support staff. To overcome this difficulty, many firms, including the market leaders, have started offering slide scanning services, whereby the company will scan and digitize glass slides for a fee.

Way Forward

Serving the small business and resident pathologists market economically is the logical progression for digital pathology system manufacturers. A number of innovative start-ups have managed to bring down the cost of scanning equipment, thereby bringing it within the affordability range of a small-scale, small-volume lab. They manufacture slide scanners which can be installed on the pathologist’s desktop, with which he/she can scan interesting cases for discussion or educational purposes. Residents and students can use such systems to capture important and unique cases.

All these developments lead us to think that while DP is currently a relatively small market, it has the potential to grow fast and reward the companies operating in this space.

In Conclusion

1. Digital pathology is a promising field within In Vitro Diagnostics (IVD)
2. Its use case extends to pathologists, labs, hospitals, teaching and research institutes, veterinarians, pharmaceutical companies and toxicologists
3. Until now, early adopters of digital pathology systems have been the pharmaceutical companies who need to do toxicological studies, and veterinary pathologists
4. One of the biggest roadblocks is that digital pathology systems as a primary diagnostic tool have not been approved by the FDA
5. The cost of the systems and the image sizes generated by DP systems are also  contributing to the slow uptake by clinical labs and hospitals
6. The technical challenges have been addressed head-on by the system vendors, and the interest shown by industry leaders like Roche, Siemens, Philips and GE points to their confidence that these issues will be sorted out over the course of time

References:

[1] Digital Pathology Association, Glossary of terms. Retrieved online on 21^st August 2012 fromhttps://digitalpathologyassociation.org/glossary-of-terms_1

[2] Bio Spectrum Asia Interview with Mr Rajiv Enand, senior vice president, business development, Omnyx, GE Healthcare. Retrieved online on 21^st August 2012 from http://archive.biospectrumasia.com/Content/040112OTH17837.asp

[3] Gene Cartwright, Chief Executive Officer, Omnyx in an Interview. “The Promise of Digital Pathology”. Video available at http://video.ezinemark.com/the-promise-of-digital-pathology-440bd37a994.html

[4] Slide scanner for around $30K. Tissue Pathology. Available online at https://tissuepathology.com/weblog/2010/11/during-the-fall-meeting-season-while-i-attended-cap-pathology-informatics-and-pathology-visions-over-the-past-couple-of-mont.html

[5] Laboratory Economics; July 2012

[6] Simagis Live Web Application. Retrieved online on 21^st August 2012 from http://virtual-microscope.net/