Study aims to validate digital pathology for primary diagnostic use

April 1, 2016 – BOSTON. Massachusetts General Hospital (MGH) will serve as a key testing site for a multicentred instrument precision study involving Royal 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 to expert consults, running the risk for lost or damaged specimens and communication delays.

“With rising healthcare costs, we have a public responsibility to work effectively,” said Dr Jochen K Lennerz, 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 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 digitise and streamline pathology workflows and enhance multisite collaboration, with the ultimate goal to support pathways to improved diagnosis.

“Digital pathology addresses many of the inherent delays present in traditional pathology workflows and supports workplace efficiencies that can be scaled within organisations to streamline processes and cut costs,” said Russell Granzow, general manager of Philips Digital Pathology Solutions.

The aim of the instrument study is to provide evidence for regulatory purposes that Philips’ digital pathology technology is valid and reliable for primary diagnostic use. If the study proves successful, the potential exists for the Food and Drug Administration (FDA) to streamline the regulatory clearance pathway for WSI moving forward.

Source: Massachusetts General Hospital