GE Healthcare and the University of Pittsburgh Medical Center (UPMC) recently announced they were beginning a joint venture in digital pathology. Together, they formed Omnyx, LLC, which would build and market a system for digital pathology. To date, digital pathology is a market that’s only been nibbled at the edges, and is primarily the domain of microscope companies such as Zeiss, Nikon, and Olympus. However, a small number of companies, bolstered by advances in digital image-gathering, are entering what is predicted to become a $2 to $4 billion industry.

Digital Pathology
Simply put, digital pathology is the utilization of digital photography to capture images on microscope slides. In the past (the early 1990s), there were a number of technical problems with digital imaging of anatomic pathology samples. Digital cameras captured the microscope slide images and stored them. However, the resolution of the digital photographs was not competitive with microscope optics and storage space was limited. A massive amount of data storage was required if the images of an entire microscope slide were to be archived. In addition, the task of capturing the entire microscope slide contents was time-consuming and laborious.

Dick Soenksen, CEO of digital pathology company Aperio Technologies, Inc., believes there are four requirements for effective digital pathology systems. They are:

1. Scanning ability.
2. Software to manage digital slides. In digital radiology they are called PACS (picture archiving and communication systems).
3. Information management systems.
4. The ability to perform image analysis on the digital slides.

Aperio Technologies, Inc.
If there is a leader in digital pathology systems–and it’s not clear that there is one–Aperio is probably it. Their headquarters is in Vista, California, with a European office in Bristol, U.K. Dick Soenksen, CEO of Aperio, says, “We are focused on digital pathology. That’s the only thing we do and it’s the only thing we’ve ever done. From our perspective, digital pathology is managing the information that’s generated by being able to digitize entire slides.”

One of the more interesting components of Aperio is their Digital Slide Scanning Service. Rather than invest in a system, the pathologist can ship their slides to Aperio and the company will use the ScanScope Scanner to digitize the slides, which are then returned along with a CD or DVD or via Internet access. Although the digital pathology market’s goal is undoubtedly to have all pathologists, labs, and hospitals using their technology in-house, this is a potential way to get pathologists to digitize early.

BioImagene
Cupertino, California-based BioImagene focuses on imaging systems for life sciences and digital pathology solutions. Mohan Uttarwar, President and CEO of BioImagene, says that their core competencies are, “The digitization of microscope slides, bringing in high-resolution image management, searching, mining of imaging data, and image analysis. Finally, the power of the Internet can be used to manage information, whether it’s a clinical report, educational content, peer reviews–formal or informal–or second opinions. All these pieces put together are something we as a company have focused on.”

Uttarwar cites four issues that are slowing adoption.

1. Lack of standardization.
2. Psychology, or resistance on the part of pathologists.
3. Ease of use and high quality.
4. Pricepoint.

Psyche Systems Corporation
Psyche Systems (Milford, MA) is not a digital pathology company per se, but a laboratory information system. They offer a number of different solutions for information management in a variety of laboratory areas, including anatomic pathology. Their AP solution is called the WindoPath Anatomic Pathology Information System, which has a modular, customizable design and can be integrated into several different laboratory information systems.

MIMvista Corporation
Based in Cleveland, Ohio, MIMvista recently made the news–somewhat contrary to Psyche’s comments about PocketPath–because of their development of a pathology imaging system specifically for Apple’s iPhone. MIM stands for Multi-modality Imaging, which has its roots in a digital radiology system dubbed Fusion.

Omnyx
As mentioned earlier, in June 2008, GE Healthcare and the University of Pittsburgh Medical Center entered into a joint agreement to start a digital pathology device company called Omnyx. Omnyx will be headquartered in Pittsburgh and also have a site in Piscataway, NJ, in addition to facilities in Israel and in Albany, New York. As yet, Omnyx does not have an actual product, although they plan to have a prototype device developed by the end of 2008 and expect to launch a product in 2010. Gene Cartwright, CEO of Omnyx says, “We believe it will be a little less than two years before we have a product. I think that we’ll be able to describe it in high level detail by the end of this year, but it’s the sort of product that needs FDA approval and that adds a certain amount of time to it.”

Cartwright believes the reason the field of digital pathology is receiving so much interest at the moment is that some of the technical hurdles are close to being solved. “The main ones are speed of acquisition of an image, quality of the image, ability to navigate around the image without having to wait for the image to come up, and then the ability to stream images. The cost of storage has dropped by 30 to 40 percent a year.”

Educational Use
John Woosley, MD, PhD, Professor of Pathology at the University of North Carolina at Chapel Hill, notes an increased use of digital slides in medical education. He sees it as an opportunity for medical schools to cooperate and share teaching materials, primarily because once a slide has been scanned, it costs nothing to duplicate

Conclusion
As noted, pathology is one of the last areas of clinical medicine to become digitized, following radiology and cardiac imaging. Typically the domain of microscope companies like Nikon, Zeiss and Olympus, a number of small companies have entered the market with new optics technology and digital information management software.

Although a number of companies and researchers have approached digital pathology over the last ten to fifteen years, they were hampered largely by the difficulty of acquiring high-resolution images of the entire microscope at high enough quality to be clinically useful. As digital image capture technology improved along with increased digital storage capacity at lower prices, digital pathology may have reached a tipping point where the technology is available at a reasonable cost.

It’s not clear how large that market may actually be. Omnyx’s Cartwright says, “The assumption is the market will adopt digital pathology at the same rate that digital radiology was adopted. So in several years we believe–and at the price points we’re assuming the market will support–that the market will be worth about $2 billion.”

Aperio’s Soenksen is more optimistic. “We’ve looked at the market and we’ve made a hypothetical full-adoption in the market and say it’s close to $4 billion a year. That’s about twice the size of what GE had in their analysis. We see more value in digital diagnosis that could be applied to automate things that pathologists are currently spending time on.”