by
Gus Iversen, Editor in Chief | November 29, 2017
From the November 2017 issue of HealthCare Business News magazine
Philips gets FDA approval for digital pathology solution
Disruption is a buzzword that gets thrown around too much in health care, but it seems safe to say that digital pathology is poised to completely disrupt the clinical lab workflow. What is typically accomplished by combining biopsy specimens with delicate glass slides and carefully focused microscopes is undergoing a computerized upgrade.
In April, Philips IntelliSite Pathology Solution became the first whole-slide imaging system that can be used to review and interpret digital surgical pathology slides prepared from biopsied tissue for primary diagnostic use. Until then, the system was only approved by the FDA to be used as an aid to the pathologist when detecting HER2 expression in breast cancer.
The FDA evaluated data from a clinical study that involved about 2,000 surgical pathology cases. It was one of the largest studies that directly compared the use of digital pathology to conventional optical microscopes.
Sixteen pathologists at Cleveland Clinic, the University of Virginia, Miraca Life Sciences and Advanced Pathology Associates performed about 16,000 reads of the cases. The results showed that the diagnoses made using PIPS were comparable to those made using the conventional method.
“It allows pathologists to simplify access to histopathology information and work more efficiently,” Russ Granzow, general manager of Philips Digital Pathology Solutions, told HCB News. “The pathologists will have the agility to view digital images and aim to extend collaboration with peers, with the aim of increasing diagnostic confidence.”
Digital pathology has been a major focus for Philips in recent years. In June 2016, the company acquired PathXL’s digital pathology portfolio. More recently in March, it partnered with a developer of artificial intelligence technology for pathology called PathAI.
