The Digital Pathology Association (DPA) is a new non-profit organization formed to advance the education and use of digital pathology applications in health care and define best practices for the industry. Dirk Soenksen, President of the DPA, spoke to DOTmed about the organization and about the digital pathology field.

Soenksen explained that the field of pathology involves examining tissue and cells on glass slides under a microscope to determine, for example, if the cells are cancerous or not. Pathologists are critical to the early detection of cancer. There are literally hundreds of millions of glass slides prepared annually for biopsies and related procedures--a very labor intensive field involving hours every day looking at these slides under the microscope. Digital pathology has transformed pathology in a manner similar to radiology, where the use of old-fashioned film X-rays are giving way to digital radiology and PACS (picture archiving and communication systems).

In a digital pathology environment, glass slides are digitized and the resulting digital slide images are viewed on a computer monitor. Digital slides can be shared via a network, including the Internet, obviating the need to send glass slides through the mail. Computer programs, in the form of image analysis algorithms, can be used to analyze digital slides and perform complicated tasks-counting cells, finding cancer cells, or other rare events such as small microorganisms associated with infectious diseases. "The ability to digitize slides allows the whole field of pathology to achieve new heights in terms of efficiency, automation, accuracy, objectivity, which all increase value to the patient," Soenksen says.

Soenksen is also the chief executive officer of Aperio, a company that provides systems and services for digital pathology. "Aperio is the pioneer and leader in the emerging digital pathology market. We've been at this for about ten years, and the field is now emerging to the point where going digital is no longer a question of if, but when. The DPA was formed because some of the barriers to adoption are clearly understood. There is a sense that if we bring together resources from industry and expertise from the pathology community, we can overcome some of these barriers more quickly than any one company can on its own."

The DPA is interested in accelerating adoption of digital pathology, and the number one obstacle to adoption is education, Soenksen points out. "People aren't going to adopt what they don't understand. So broadly educating pathologists and others about what digital pathology can do for them will lead to adoption. The DPA is a nonprofit with a focus on education. There are certain standards, for example, a common file format, that if followed by everyone will accelerate adoption. The DPA is focused on education, standards, and best practices that everyone can agree upon. We educate the market and everyone benefits because the market grows. The end-user benefits because they can use digital pathology to increase quality and efficiency, which can lead to increased revenue and in some cases, increases in diagnostic accuracy."

One example of the growing adoption of digital pathology is the use of digital pathology products and services by veterinary pathologists, who are often employed by pharmaceutical companies focused on drug discovery. Veterinary pathologists perform studies to understand the effect of drugs, and to assess the toxicity and cell damage suggestive of how a drug might act in humans. The adoption of digital pathology in drug discovery is quite high, Soenksen says. "The value the technology brings to the drug discovery process is significant, in large part because of the efficiencies that biopharma companies can achieve by investing in digital pathology." Whereas in traditional glass slide studies, many pathologists are often brought together to study thousands of glass slides, with digital pathology, the pathologists can examine the same information in an online format, even simultaneously.

A Component of Health IT

Digital pathology technology is part of healthcare IT, a significant part of the Administration's health care agenda. The DPA wants to promote digital pathology's benefits so it can be included in healthcare IT spending. The glass slide in pathology has value to the patient for diagnosis and second opinions. For many patients, having an electronic record including digitized slides would be optimal in tracking the progress in their medical conditions. Therefore, patients should be made aware of digital pathology's benefits for inclusion in health records-perhaps linking to an online slide repository to compliment one's records in an online repository such as those from Microsoft or Google.

The information contained in a digital slide is immense, comprising multiple gigabytes of imagery data. Approaches for digitizing glass slides include image tiling systems, which capture and assemble thousands of small images into a digital slides; and line-scanning systems which use a linear array detector to create a smaller number of image stripes (conceptually similar to how a fax machine works) which are assembled into a digital slide. A typical microscope slide scanner has a scanning resolution of around 50,000 dots per inch, which is several orders of magnitude larger than the 300 dots per inch resolution of typical fax machine. Once a digital slide has been created, one of the challenges is viewing this imagery data via a network like the Internet.

"The techniques used to view digital slide images via the Internet are conceptually similar to Google Earth, which facilitates efficient access to any region of the world, without having to download the entire Google Earth database to one's computer. Digital pathology utilizes client/server technology that enables efficient access to portions of a digital slide, but does not require downloading all of the imagery data comprising a digital slide."

Conference Focused on Digital Pathology

The DPA recently hosted the fifth annual Pathology Visions conference in San Diego, CA, which brought together physicians and pathologists focused on clinical and drug discovery applications. The attendees educated each other about the state of the art and best practices. Soenksen reported that the event went very well, and attendance was up over the previous year, unusual in today's environment. "The feedback was tremendous; we only heard positive comments about the newly formed Digital Pathology Association. There is recognition the digital pathology market is poised to take off. Companies in the market have grown rapidly, but generally everyone is still in the early stages. Some of the barriers are so clearly identified now that there is broad recognition that by pooling resources we are more likely to overcome those barriers than in individual companies trying to overcome the barriers by themselves."

One such barrier is setting standards. Establishing standards for the industry is a common goal for companies that are otherwise competitors. The DPA can also work on establishing regulatory guidelines and perspectives. "Some digital pathology products are FDA cleared for some applications but not others, so another common goal is working with the FDA to establish how clinical studies should be conducted to allow this technology to be marketed more broadly for clinical use. In addition, reimbursement strategies are better undertaken by an industry group. Everyone benefits if potential users are educated. Promoting digital pathology as a capability brings value to the industry and the end-user."

Future plans for the DPA are to add to the current board of directors, to nominate and elect three pathology leaders to the board so the DPA will have a balanced view from the industry and the end-user community. One of the certain plans is to hold a more comprehensive Pathology Visions conference in 2010. Soenksen summarizes the organization's plans: "We'd like to have increase participation by clinicians and perhaps get the FDA involved as well. We also believe that an IT (information technology) and an informatics track would be well received by Visions attendees."

DPA also hopes to offer continuing medical education (CME) credits for physicians attending Visions 2010. It plans to promote digital pathology at different conferences such as ASCO (clinical oncology), HIMSS (image management) or AACR (cancer research; conferences where attendees will benefit by learning about digital pathology. This month, the FDA is assembling a panel of experts to hear from many of the stakeholders in the industry, presumably so they can provide guidance about how companies can get their products approved or cleared for making diagnoses on a computer monitor. The DPA will be presenting to the FDA panel on digital pathology technology and the state of adoption.