The Application, Challenges, and Advancement Toward Regulatory Acceptance of Digital Toxicologic Pathology: Results of the 7th ESTP International Expert Workshop (September 20-21, 2019). (June 2021)

• Record Type: Journal Article
• Authors: Schumacher, Vanessa L.; Aeffner, Famke; Barale-Thomas, Erio; Botteron, Catherine; Carter, Jonathan; Elies, Laëtitia; Engelhardt, Jeffery A.; Fant, Pierluigi; Forest, Thomas; Hall, Peter; Hildebrand, Deon; Klopfleisch, Robert; Lucotte, Thomas; Marxfeld, Heike; Mckinney, LuAnn; Moulin, Pierre; Neyens, Elizabeth; Palazzi, Xavier; Piton, Alain; Riccardi, Elena; Roth, Daniel R.; Rousselle, Serge; Vidal, Justin D.; Williams, Bethany
• Is Part Of: Toxicologic pathology. Volume 49:Number 4(2021)
• Page Start: 720
• Page End: 737
• Publication Date: 2021-06
• Subjects: digital pathology -- good laboratory practice -- nonclinical -- regulatory -- toxicologic pathology -- whole slide imaging -- validation; Pathology -- Periodicals; Toxicology -- Periodicals; Pathology; Toxicology; 615.9
• DOI: 10.1177/0192623320975841
• Languages: English
• ISSNs: 0192-6233

Abstract

With advancements in whole slide imaging technology and improved understanding of the features of pathologist workstations required for digital slide evaluation, many institutions are investigating broad digital pathology adoption. The benefits of digital pathology evaluation include remote access to study or diagnostic case materials and integration of analysis and reporting tools. Diagnosis based on whole slide images is established in human medical pathology, and the use of digital pathology in toxicologic pathology is increasing. However, there has not been broad adoption in toxicologic pathology, particularly in the context of regulatory studies, due to lack of precedence. To address this topic, as well as practical aspects, the European Society of Toxicologic Pathology coordinated an expert international workshop to assess current applications and challenges and outline a set of minimal requirements needed to gain future regulatory acceptance for the use of digital toxicologic pathology workflows in research and development, so that toxicologic pathologists can benefit from digital slide technology.