On April 12, 2017, FDA granted marketing clearance for the Philips IntelliSite Pathology Solution (PIPS), the first Whole Slide Imaging (WSI) System cleared for use in primary disease diagnosis. As the first WSI system authorized for this purpose, the clearance represents a turning point in the adoption of digital pathology methods in clinical laboratories by enabling the use of WSI systems in routine pathology workflows. WSI systems, like the PIPS, create facsimile digital images of pathology slides that can be electronically viewed, managed, and stored. The milestone clearance paved the way for marketing clearance of additional WSI systems through establishment of a new Class II device classification for “Whole Slide Imaging Systems”, which will likely reduce the previous barriers for broad integration of digital techniques in clinical laboratories.
WSI systems, like PIPS, are a crucial piece of the digital transformation coming to pathology processes. In a press release recognizing the landmark clearance, Esther Abels, the Chair of the Regulatory Task Force with the Digital Pathology Association notes, “The clearance for [PIPS] is a major milestone in pathology in the US and is revolutionary in medicine. PIPS is not only developed with aim to increase efficiency and promote collaboration, it is also the stepping stone towards computational pathology with the purpose to improve diagnostic accuracy, precision, and in the end, patient care.” The computational pathology workflow, facilitated by WSI, will enable pathologists to use platforms, like Flagship’s Computational Tissue Analysis (cTA™), to support patient selection and treatment decisions in immuno-oncology and other diseases. The cTA™ platform takes advantage of the pathologist’s training and experience to develop image analysis solutions for the detection of cells and biomarkers on digital images created by WSI systems. Another advantage of computational platforms is high-throughput quantification of multiple parameters across whole tissue sections, which enhances a pathologist’s diagnostic capabilities.
WSI systems also hold great promise for increasing the efficiency and capabilities for pathology workflows in other areas. Pathologists can use WSI systems for accessing a global network of peers for collaboration, consultation, and review. Through electronic display of digitized slides, pathologists are also no longer limited to viewing one slide at a time on a light microscope. Multiple images, including archived digital images, can be simultaneously viewed on a computer monitor. Finally, WSI systems support an integrated analysis of disease by allowing pathologists, clinical investigators, and other scientists to integrate tissue-based histopathology data with biomarker data from other methods, such as liquid biopsies and genetic testing, into data management systems.
As the development of precision medicine therapeutics rapidly expands the complexity of treatment decision-making, the number of diagnostic tests needed to create a complete disease diagnosis continues to grow. Pathologists play a critical role in precision medicine as they must accurately and efficiently assess the diagnostic tests to determine the most appropriate treatment option. Advancements like WSI and cTA™ will strengthen a pathologist’s ability to partner with other scientists and physicians to solve some of the world’s most difficult medical problems.
Scientific and Pathology Teams,