Massachusetts General Hospital To Begin Clinical Validation Study Using Philips’ IntelliSite Solution
News today courtesy of Philips announcing MGH as a primary site for a clinical validation trial based here in the United States for reproducibility of whole slide imaging (WSI) to glass slides. The PI on the study, Dr. Joe Lennerz has been involved with imaging and clinical trials for some time and also has interests in molecular pathology. Aside from conversion of slides to digital images and workflow advantages over analog, I think there is another major focus here being increasingly recognized by both academic and community hospitals — that is that WSI provides a bridge from morphology to molecular. With increasing demand and need for tissue preservation and smaller samples obtained for more testing than ever before, preservation of morphology to guide additional molecular analysis, perhaps in disparate locations with next generation sequencing, remote review of images will increasingly be important.
Instrument precision study seeks to gain new research insights to evaluate digital pathology for primary diagnostic use to advance digital pathology adoption in the United States
Amsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA) announced Massachusetts General Hospital (MGH) will serve as a key testing site for a multi-centered instrument precision 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.
“Digital pathology addresses many of the inherent delays present in traditional pathology workflows and supports workplace efficiencies that can be scaled within organizations to streamline processes and cut costs,” said Russell Granzow, General Manager of Philips Digital Pathology Solutions. “Philips is excited about the clinical study MGH is conducting to investigate the reproducibility of digital pathology system in the clinical diagnostic setting.”
Category: Anatomic Pathology, Clinical Laboratories, Data Management, Device Manufacturers, Digital Pathology News, Government, Laboratory Informatics, Laboratory Management & Operations, Medical Research, Pathology News, Science, TeleHealth, Vendor products, Web/Tech, Whole slide