Global Digital Pathology 2019
What You Need to Know to Get Started

Early Entrant Philips Leading the Digital Pathology Market

Philips, the first vendor to receive FDA approval, leads the digital pathology market for primary diagnosis across the world. Multiple customers are 100% digital for histology across their entire pathology department. Philips is widely considered as an all-encompassing solution, offering combined scanner, workflow, and PACS capabilities. Scanned slides are described as very high quality and as the most natural-looking of any vendor’s. The image-management tools are good. One downside is the solution’s proprietary image format, which creates significant barriers to image sharing with other vendor solutions. The scanner also currently lacks fluorescence or z-stacking capabilities.

Sectra Leveraging Radiology PACS Expertise to Grow in Digital Pathology

Sectra’s small customer base leverages the digital pathology solution as an outgrowth of Sectra's radiology PACS. Reference customers read thousands of cases per year for primary diagnosis, and KLAS validated one organization that is fully digital for primary diagnosis. Sectra’s workflow and image-management functionality stand out compared to other vendors’. Potential customers appreciate the flexibility that comes from the solution being scanner agnostic—customers validate using 3DHISTECH, Hamamatsu, Huron, Leica, and Roche scanners with the Sectra PACS. Some customers use the solution’s image-analysis functionality to help count cells. Almost all customers using the solution for primary diagnosis are in Europe; the solution does not yet have
FDA approval.

Leica, Other Pathology PACSs Struggling to Gain Ground

A number of new vendors are vying for consideration, as is the case in any new technology area. Leica Biosystems, the second vendor to receive FDA approval, has customers using their all-in-one solution for primary diagnosis. While the scanner receives high consideration, early feedback suggests the PACS/workflow tools are weaker than Sectra’s or Philips’. Inspirata, who acquired Omnyx from GE Healthcare, has released an upgraded PACS with good tools; only a couple of customers are live (all in Europe). Roche Diagnostics has a strong presence in this research but very limited PACS capabilities.

KLAS has also validated several smaller, scanner-agnostic PACS vendors being considered,
including TRIBVN Healthcare—who has a growing presence in France and one validated customer in Canada— and Kanteron Systems—who has signed customers in Mexico, Spain, and Thailand (one in each region).

Identify your pathologist champions

Evaluate your pathology workflows and lab infrastructure for viewing large image files

Tweak specimen/slide preparation based on scanner selected

Determine your workflow engine—LIS-driven approach or PACS-driven approach

Start with a group of champion pathologists who want to move
to digital pathology—let them lead the charge

Work out system kinks before rolling out to all pathologists

Allow for individual system validation and testing

“Take the time and money to let every pathologist do his or her own individual validation so that the pathologists will trust the system. . . . We first introduced about 20 test cases for the pathologists to do both digitally and through the microscope so that they could note any differences.
Proving that the system is safe isn't necessary, but doing that is a good affirmation that the system works.”
—Director of Pathology

After validation and testing, create a timeline to move to a fully digital workflow

Q: What benefits can my organization expect from moving to digital pathology?

A: Interviewed organizations cite three main benefits: (1) improved quality, (2) improved efficiency, and (3) remote-reading capabilities.

Improved Quality

• Remote consultations/second opinions within the organization

• Residents able to see what supervisor/other pathologist is viewing
• Annotations are saved and can be shared
• Slide images make it easier to ensure all parts of the specimen on a slide are viewed
• Slide thumbnail heat maps (depending on the system) can ensure pathologists have viewed the whole slide

Improved Efficiency

• Less time spent sorting, pulling slides—generally can save half an FTE depending on volume, though they may need to be repurposed to do other tasks, like running scanners

• Faster access to old images (as long as image is available in the archive, access is immediate compared to several hours/days)

• Multi-slide comparisons are much easier (can look at slides side-by-side or even superimposed and auto-aligned)
• Work by multidisciplinary teams, preparation from tumor board much easier and more organized

Remote-Reading/Telepathology

• Ability to read pathology images remotely; also allows for central hospital to read frozen sections for smaller hospitals in a pathology network; also facilitates telepathology networks (currently rare)