Digital Pathology Primary Diagnosis is Approved – Is Your Lab Ready for the Future?

Earlier this month, there was an exciting announcement that Leica received their FDA 510(k) clearance to market a digital pathology whole slide imaging system for primary diagnosis. This comes on the heels of Philips’ groundbreaking announcement of FDA clearance in late 2017, which was the first device ever cleared for primary diagnosis. These advancements are initiating significant momentum in the adoption of digital pathology platforms for clinical use.  

Leica and its Aperio platform have long been a pioneering force in digital pathology in both research and clinical applications. For nearly 20 years, XiFin has been integrating digital pathology platforms including, Leica Aperio devices, to facilitate technical and professional revenue sharing strategies and quantitative image analysis. Other initial use cases included an integrated workflow for performing remote microdissection of whole slide images and secondary consultations, but these use cases represent only the beginning of digital pathology use in the laboratory.

In preparation for the full adoption of digital pathology for primary diagnosis, it is critical that labs consider how it will be integrated into the lab workflow and overall IT infrastructure (see diagram below). Successful digital pathology system integration will allow the lab to take advantage of the following:

• Improve case throughout
• Case triaging via artificial intelligence
• Integrated image analysis
• Streamlined slide logistics
• Integrated reporting (with images and analysis)
• Digital secondary consultations and precision medicine collaboration
• Pathologist workplace ergonomics

The key word is workflow!  Successful integration of digital pathology in laboratories is dependent on workflow, including seamless integration with the Laboratory’s Information System (LIS). There are many capabilities or functionality that a future-proof LIS must have. For example, the LIS must be fully integrated with histology automation such as the Leica Cerebro or the Ventana Vantage platform. It must also be able to pass case information to the digital pathology system, as well as prepare barcoded slide labels that can be read by the imaging device. Once slides are scanned and the whole slide images are ready for review, pathologists should be notified of their availability via the LIS.  The ideal digital workflow includes access to all case-related whole slide images via an image viewer within the LIS. Pathologists can then capture regions of interest and include them in the LIS report if desired. If the pathologist is utilizing automated image analysis, they should be able to seamlessly incorporate those results in the LIS and final report.

A future-proof LIS must be capable of managing more than just the digital pathology workflow.  In some cases, additional testing may be necessary, which would require pathologists to have the ability to order these tests in the LIS to initiate the pending test workflow process. Occasionally, a secondary consultation is necessary, making an LIS with the ability to digitally share cases with colleagues important. Additionally, many forward-looking labs understand their lab’s data is valuable to precision medicine programs. An LIS that facilitates the test result’s data being pushed from the LIS to a precision medicine collaboration or informatics platform will be paramount.

With the quickly evolving use of artificial intelligence tools, the ability to triage cases into high or low priority will steadily increase. This workflow step will need to be inserted after the slide scanning process and must also be integrated with the LIS. Using these innovative tools, pathologists can prioritize cases that have been pre-selected as high-risk. While every case is important, this technology represents a significant opportunity to use technology to reduce the lab’s risk of losing or misdiagnosing a critical case.

If the laboratory’s information system is not enabled to support the digital pathology workflow, the lab will be limited in its ability to take advantage of numerous opportunities. The lab of the future must be prepared with a digital pathology LIS (DPLIS).

Interested in learning more? Check out our complimentary white paper “The Build vs. Buy Conundrum of Laboratory Information Systems.”