Digital Primary and Peer Review
Comprehensive digital pathology has arrived at Charles River to accelerate discovery and safety programs around the globe. The average toxicology program involves the assessment of 30,000 slides, consuming considerable time and effort. With the application of new digital pathology software and equipment, tasks that once took hours have been reduced to minutes, with the added advantage of enhanced collaboration and peer review.
We’ve deployed a suite of digital slide scanners and an integrated slide management system to connect our team of nearly 150 pathologists with each other and you, their clients. The scanners produce whole slide images (WSI) of microscopic slides at a range of magnifications, allowing fit-for-purpose use for diverse activities such as diagnostic primary and peer review, machine learning and deep learning-based image analysis, and stereology.
Digital Primary and Peer Review
Our digital primary and peer review capabilities enable you to interact virtually with our team, and consultant pathologists. Digital primary slide review can be done anywhere in the world using eSM through a secure interface. Presently, primary slide review is only established for Discovery and non-GLP work; however, we expect to have scanners validated for primary review in 2021. Digital peer review is already in place for all study types, adding flexibility for this critical toxicology best practice.
Our partnership with Deciphex further advances capabilities in both digital primary and peer review with the implementation of Patholytix Preclinical software. This innovative slide management system was built with the pathologist in mind with an outstanding ergonomic and user-friendly experience for the peer review pathologist.
When whole slide imaging is not immediately available, many of our sites and pathologists use tools like standard microscope cameras and virtual reality systems (Augmentiqs) to collaborate and consult on glass slides. Whether you wish to dial in to our microscopes or use tools like Skype to engage real-time with our pathologists, telepathology solutions add flexibility to the WSI production and review involved in standard study conduct.
Machine and Deep Learning-Based Tissue Image Analysis and Stereology
A pilot program for the evaluation of artificial intelligent solutions has resulted in the deployment of the Aiforia, Deciphex, and Visiopharm platforms to further enhance our existing WSI and stereology capabilities with machine and deep learning image analysis. Our global working group of pathologists and scientists have expertise in developing algorithms that can drive your scientific discoveries and safety evaluations. while in-house and partnering computer scientists, statisticians, and other specialists contribute to study design, development, and testing. These sophisticated image analysis algorithms and stereology methods can be applied as decision support tools for pathologists or for producing primary data for nGLP and GLP studies.
Frequently Asked Questions (FAQs) about Digital Pathology & Peer Review
What is digital pathology?
Digital pathology involves the secure and SOP-driven acquisition, management, and interpretation of pathology information generated from a digitized glass slide, or whole slide image (WSI).
What is a digital pathology peer review?
A digital pathology peer review is a SOP-driven review of the study pathologist’s evaluation of tissue changes by a qualified peer-reviewing pathologist using digital whole slide images (WSIs).
Can WSIs be generated from GLP studies?
Yes. WSIs can be generated for any type of study (Discovery, non-GLP, GLP).
Can these WSIs be used for GLP digital pathology peer review?
Yes. We have procedural controls in place to support non-GLP and GLP peer review. We are in the process of validating our Leica glass slide scanners and eSlideManager(eSM) software and expect this to be complete by the end of 2020. Charles River will then move forward with validation of the Deciphex Patholytix Preclinical platform for GLP peer review by end of 2020. As Charles River and Deciphex engage in the validation for the intended use of Deciphex Patholytix Preclinical (formal peer review), the full chain of custody of the images and metadata will be covered as part of the validation strategy to ensure the entire workflow, from image capture (through scanner and image repository validation) to actual upload and download of images/metadata, is addressed from a security, functionality and compliance standpoint. It should be noted that, to ensure full compliance under current regulation, the sponsor hardware and software must be also be covered by a validation cycle of its own, using the sponsor processes for these activities in completing the end-to-end validated state of this particular application. CRL and Deciphex can provide guidance to sponsors in the approach and elements required to ensure that GLP compliance can be claimed for the entire chain of custody.
What slide scanning capabilities exist at Charles River?
Charles River has a global fleet of integrated whole slide scanners and offers comprehensive quantitative pathology services, including GLP morphometrics and stereology. Our slide scanner fleet is composed predominantly of Leica Biosystems (Aperio) AT2 ScanScopes as well as two Hamamatsu NanoZoomers. In North America, we have the capability to directly digitize glass slides in Ashland, Durham, Frederick, Mattawan, Reno, Senneville (Montreal), and Spencerville. In Europe, we have the capability to directly digitize slides in Den Bosch, Edinburgh, Evreux and Lyon.
What glass slide scanning hardware is used at Charles River?
Digital scanning routine hematoxylin and eosin (H&E)-stained and many immunohistochemistry (IHC) glass slides uses the Aperio AT2 manufactured by Leica Biosystems. IHC slides generated for stereology endpoints are scanned using either the NanoZoomer manufactured by Hamamatsu or the VS120 manufactured by Olympus. These scanners can digitize a slide at a preset magnification. The most commonly used magnifications in our industry are 20x and 40x. Increasingly our clients are requesting 40x scans which require more scanning time (approximately 8 minutes/slide) and memory for storage (gigabytes).
What digital pathology software is used at Charles River?
Aperio eSlideManager (eSM), available through Leica Biosystems, is currently the main digital pathology software management solution in place within Charles River for all uses including digital pathology peer review. Charles River is also engaged in a partnership with Deciphex whereby the Patholytix Preclinical software platform is available for a complete digital pathology management solution, including digital peer review.
Also available for image analysis and stereology services is newCAST™ software (Visiopharm-Durham, Edinburgh, Kuopio, and Montreal). Programs exploring newer artificial intelligence deep learning software for targeted, solution-based application are available through licenses we have with Visiopharm (Durham) and Aiforia (Ashland, Durham, Frederick, Montreal, Reno, Spencerville, and Shrewsbury). Charles River is also engaged in a partnership with Deciphex for a complete digital pathology management solution.