CEO SUMMARY: The FDA’s clearance of the first digital pathology system for use in primary diagnosis will be a disruptive force for pathologists in the coming years. At the University of Southern California Keck School of Medicine, pathologist Clive Taylor, MD, predicts that the benefits of whole slide imaging and digital pathology will enable pathologists
Digital PathologySkip to articles
Digital pathology is an image-based information environment that is enabled by computer technology to allow for the management of information generated from a digital slide. It is enabled in part by virtual microscopy, which is the practice of converting glass slides into digital slides that can be viewed, managed, and analyzed on a computer monitor. With the advent of whole-slide imaging, the field of digital pathology has exploded and is currently regarded as one of the most promising avenues of diagnostic medicine to achieve even better, faster and cheaper diagnosis, prognosis and prediction of cancer and other important diseases.
Digital pathology also holds the promise of interconnecting pathologists around the globe in ways that will advance diagnostic accuracy and improve patient outcomes.
In pathology, trained pathologists look at tissue slides under a microscope. The tissue on those slides may be subjected to staining to highlight structures. When those slides are digitized, they then have the potential to be numerically analyzed using computer algorithms. Algorithms can be used to automate the manual counting of structures, or for classifying the condition of tissue such as is used in grading tumors.
This could reduce human error and improve accuracy of diagnoses. Digital slides are also, by nature, easier to share than physical slides. This increases potential for using data for education and consultations between two or more experts.
The technology is not yet approved by the FDA for primary diagnosis. Unlike digital radiology where the elimination of film made return on investment (ROI) clear, the ROI on digital pathology equipment is less obvious. The strongest ROI justification includes improved quality of healthcare, increased efficiency for pathologists, and reduced costs in handling glass slides.
Thus the high cost of implementing this technology is slowing adoption of these systems by smaller private pathology groups. It is estimated that around 1,000 pathology labs worldwide own and use digital pathology systems on a regular basis.
Smaller organizations often believe they must engage in full adoption, which means digitizing all cases and every glass slide, then reading all the images on a monitor. Partial adoption is also possible, though, and new technology is expected to allow smaller pathology groups to go digital via a cloud-based pathologist workflow solution.
CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administration for review of its whole slide imaging system. Following the FDA’s decision to clear this system for sale earlier this month, and informed by their
CEO SUMMARY: One 15-member pathology group said adopting digital pathology will give it more competitive advantage. Advanced Pathology Associates (APA) in suburban Maryland, was one of four sites that participated in the clinical study of the Philips IntelliSite Pathology Solution application for FDA clearance to use the system for primary diagnosis. The experience was of
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone on April 12 when the FDA cleared the Philips digital pathology system for sale in the United States. Now pathologists can use the system to perform primary diagnoses and get paid for those professional services. It is expected that this regulatory
IN RECENT WEEKS, pathology laboratory clients of the Omnyx digital pathology system learned that the joint venture is ending. Company officials tell these customers that their digital pathology systems will continue to receive service.
Omnyx was formed in 2008 as a joint venture between GE Healthcare and the University of Pittsburgh Medical Center (UPMC). Its goal
CEO SUMMARY: For years, the adoption of digital pathology has lagged behind the predictions of its advocates. That has encouraged one digital pathology company—Inspirata, Inc., of Tampa—to come up with a different business strategy designed to help anatomic pathology labs address the barriers and capital costs involved with establishing a digital pathology system. The Ohio
CEO Summary: It is one of the first clinical collaborations of this type to be anchored by use of digital pathology. Pathologists at the medical schools of the Second Affiliated Hospital of Zhejiang University in Hangzhou, China, and the University of California Los Angeles (UCLA) are exchanging cases and sharing knowledge. During the first 18
CEO SUMMARY: Digital pathology holds the promise of interconnecting pathologists around the globe in ways that advance diagnostic accuracy and improve patient outcomes. One pioneering digital pathology collaboration involves the pathology departments at the medical schools of the University of California, Los Angeles (UCLA) and Zhejiang University in Hangzhou, China.
PART ONE OF A SERIES
CEO SUMMARY: Digital pathology is considered to be one of the more disruptive technologies now finding acceptance in anatomic pathology. Since founding Aperio Technologies, Inc., of Vista, California, in 1999, President Dirk G. Soenksen, M.S., M.B.A., has been in the forefront of this important trend. In part one of this two-part interview, Soenksen discussed the
Editor’s Note: Guest writer Martin Perry attended the FDA’s advisory panel on digital pathology conducted earlier this month. He is CEO of The Perry Group and has extensive experience in imaging and healthcare. He offers his insights from the FDA proceedings on digital pathology imaging.
DIGITAL PATHOLOGY CONTINUES to gain acceptance at a steady but measured