Digital Pathology
Safety Assessment
Daniel Rudmann

Major Advance for Pathologists Going Digital

Recent Charles River study describes first fully GLP digital pathology workflow

Technology and science enable us and, in Safety Assessment, our regulatory partners to provide a box for us to operate.  The digital camera and the whole slide scanner (WSS) were disruptive technologies for multiple industries including pathology.  Combined with the “World Wide Web” and advances in computing power and improved economics of computer memory, telepathology and digital-based machine learning were transformed.  Yet, we work in an industry that must protect animal and human health and new approaches to collecting and analyzing our data should be implemented carefully and thoughtfully.

In this peer reviewed manuscript, we describe with our partners from Astra Zeneca and Deciphex, a GLP-validated digital pathology workflow that was used for a candidate drug prior to human clinical testing.   

CRL validated the CRO-facing portion of the digital workflow and AstraZeneca did the same for the client facing workstation.  Deciphex added the necessary technical controls in their software to enable the validation. The findings were published June 1 in Toxicologic Pathology.

The digital workflow starts with a scan of the glass microscopic slides using a GLP validated Leica AT2 whole slide scanner (WSS).  These whole slide images (WSI) are transported to a secure cloud along with slide and diagnostic-level metadata. A client with the viewing software can then download the WSI locally and use their computer and monitor as a digital microscope.  The viewing software has functionality not available to a pathologist using a light microscope such as vector and pin annotations, automated blinded review, direct slide by slide comparisons, and integrated diagnostic metadata.  The client can export images for other uses and the WSI can be evaluated using machine learning artificial intelligence models developed by the client or the software provider.

This is the first fully GLP digital pathology workflow in our industry and demonstrates CRL’s commitment to quality and innovation.  Pathologists that “go digital” will be able to work more efficiently, flexibly, avoid unnecessary travel and shipment of study materials, and position their data for analytics using artificial intelligence-based technologies.  It is an exciting time for toxicologic pathology at CRL and in the broader industry.