Massachusetts General Hospital (MGH) announced that it will serve as a key testing site for a clinical analytical study involving Philips’ digital pathology whole slide imaging (WSI) IntelliSite Solution. The study is designed to show the reproducibility of the IntelliSite pathology solution in disease detection as part of the industry’s efforts to obtain regulatory clearance of WSI for primary diagnostic use. If approved for diagnosis, in contrast to the industry’s current analog process, soon pathologists could benefit from a digital system for their routine work.
The pathologist plays a critical role in the detection and diagnosis of a wide variety of diseases, including cancer. Most tissue-based diagnoses are rendered through analysis performed on a microscope using sections on glass slides. Once interpreted by a pathologist, they inform the final treatment pathway that has a significant impact on the patient and their families. In the process, providers often have to ship the glass slide samples for expert consults, running the risk for lost or damaged specimens and communication delays.
“With rising health care costs, we have a public responsibility to work effectively,” said Jochen K. Lennerz, M.D., Ph.D., principal investigator of the study. “Through the genomic revolution we have started to learn how to manage big data. Now there is a pressing need to gain access to and increase flexibility in how pathologists manage the massive amounts of imaging data we procure every day.”
As workloads increase and pressures mount to improve the diagnostic process, the need to reinvent traditional pathology workflows to increase efficiencies and better manage massive amounts of data has put a spotlight on digital pathology solutions. These technologies have been developed to digitize and streamline pathology workflows and enhance multi-site collaboration with the ultimate goal to support pathways to improved diagnosis.
“Through this study we hope to provide evidence for regulatory purposes that this technology is valid and reliable for primary diagnostic use,” added Veronica E. Klepeis, M.D., Ph.D., the key enrollment pathologist in the study.
As the personalized medicine and cancer moonshot movements are gaining visibility amongst the public, digital pathology’s role in disease diagnostics should not be overlooked. Recent discussions with the Food and Drug Administration (FDA) have the potential to streamline the regulatory clearance pathway for digital pathology WSI moving forward.