CEO SUMMARY: It’s a new joint venture with the potential to transform surgical pathology. General Electric Healthcare has extensive experience at supporting physicians’ work flow with digitized imaging systems, plus ample experience with molecular bio-markers. The University of Pittsburgh Medical Center’s pathology department is a world leader in whole-slide imaging and digitized pathology systems. Together, the two partners hope to gain FDA approval for a fully digitized pathology system in about two years.
RECOGNIZING THE OPPORTUNITY to replace glass slides and microscopes that clinical labs have used for more than a century, on June 5, GE Healthcare and the University of Pittsburgh Medical Center (UPMC) announced an important joint venture to develop digital pathology systems that can automate primary diagnosis, among other benefits.
The new joint venture is called Omnyx, LLC (www.omnyxpath.com). GE Healthcare and UPMC will each invest $20 million in the venture. Goals of this new enterprise are ambitious. It expects to develop a digital pathology system that can perform whole-slide scanning in 30 seconds. Omnyx believes it can have the digital pathology system finished with the FDA approval process and ready for market within two years.
Gene Cartwright, a veteran GE executive who will be the Omnyx CEO, calls the new digital pathology system a necessary and evolutionary change for pathology. George K. Michalopoulos, M.D., Ph.D., Chairman of Pathology at UPMC, described the digital pathology system as fast enough to “incorporate into the work flow” of a hospital-based pathology department that typically handles 1,000 slides daily. GE and UPMC estimate that whole-slide imaging and digital pathology represent a $2 billion market.
This development is significant for at least three reasons. First, it represents a major new corporate initiative to expand General Electric’s presence in anatomic pathology and in vitro diagnostics (IVD). GE is already a major global player in digital systems for radiology imaging and cardiology imaging.
Second, the willingness of GE to partner with an academic medical center, and the $40 million investment of the two partners, demonstrate its conviction that anatomic pathology is ready to “go digital.” It is widely-recognized that pathology has lagged behind radiology in moving to a fully-digital workflow. GE’s timing for entry into pathology digitization signals that it believes it can now deliver digital products that will enhance pathologists’ work flow.
Third, General Electric’s choice of UPMC as its partner is a validation of the vision of two pioneering pathologists there. Both Michalopoulos and Michael Becich, M.D., Ph.D., Professor and Chair of the Department of Biomedical Informatics at the University of Pittsburgh School of Medicine (www.dbmi.pitt.edu) have been at the forefront of efforts to create effective digital pathology systems, reaching back into the 1990s.
An Experienced Partner
Recognizing the opportunities that digital imaging offers to pathologists, Becich has worked to develop a company like Omnyx for at least 10 years and will serve as a senior consultant to Omnyx. In 1997, he and other pathologists at UPMC founded InterScope Technologies, Inc., in Wexford, Pennsylvania, to develop integrated systems for slide imaging, case flow, and clinical data management in anatomic pathology. Trestle Instrument Systems acquired InterScope in 2005 and was itself eventually acquired by Carl Zeiss MicroImaging GmbH (a unit of Carl Zeiss AG) in 2007.
“UPMC has been a pioneer in digital pathology since we founded InterScope in 1997,” Becich told THE DARK REPORT. “Interestingly, in partnership with UPMC, InterScope did a first run at this technology. However, as a small start-up and lacking the deep financial pockets of a GE or a UPMC, it wasn’t able to finish the clinical trials required to gain FDA approval. We hope to apply the lessons learned from all this prior experience in developing Omnyx.”
The Omnyx digital pathology system is expected to allow clinicians to share images via the Internet and work together to interpret results using advanced algorithms. The system is designed to support improved clinical services by pathologists while generating increased productivity by streamlining workflow and allowing pathology information to fully integrate with patients’ electronic medical records.
Bruce A. Friedman, M.D., Active Emeritus Professor, Department of Pathology at the University of Michigan in Ann Arbor, commented on the significance of the joint venture in his blog (www.labsoftnews.com) on June 5. “I have published a number of previous notes about the entrepreneurship of UPMC,” observed Friedman. “Dr. Mike Becich and his colleagues have also established the pathology department at UPMC as a national leader—not only in pathology imaging—but in all of pathology informatics. From my perspective, the deployment of practical whole slide imaging systems is a key to the future success of surgical pathology.”
Seeking FDA Approval
“Currently, this technology is largely being used for education and training,” Becich explained. “What will make the market explode is getting certification from the Food and Drug Administration (FDA) to use these instruments for primary diagnosis. Getting the FDA to approve this technology as a medical device will allow pathologists to use imaging as the primary diagnostic mode in the same way radiologists look at images as part of their work flow.”
“The workflow improvements alone are significant,” he stated. “Most large pathology practices operate in more than one location. The pathology practices at UPMC operate in 20 hospitals. We do our histology in centralized laboratories, which means these slides must be distributed back out to the hospitals. Like most centralized labs, we have a courier distribution system, which has its own inefficiencies. Further, if we have to do consults, we must package the slides and mail them among locations. Of course, glass slides sometimes break or become lost. But having a digital solution allows us to solve all of these problems at once.
“From an productivity standpoint, there would be an opportunity for pathologists to be more efficient while also handling higher volumes of cases,” observed Becich. “Potentially, the largest reductions in workforce could occur with the ancillary staffs. This includes the couriers who transport the glass slides throughout the system. It also includes the technologists who file slides when they are returned, retrieve glass slides from storage, and who also recut specimens when necessary. Digitized pathology systems will reduce or eliminate the need for this labor.”
THE DARK REPORT observes that the creation of Omnyx is a major milestone on the road to fully digitized pathology systems. It marks the long-anticipated entry of General Electric into anatomic pathology and in vitro diagnostics. With one of the world’s largest businesses in radiology and imaging, GE brings considerable clout, credibility, and experience to the Omnyx joint venture.
Plus, the $40 million bet that GE and UPMC are placing on Omnyx is a sign that the two partners are confident they can meld GE’s considerable technology base and physician work flow experience with the digitized pathology solutions developed at UPMC to create a next-generation digitized pathology system. Now the challenge is to gain FDA approval and then convince pathologists that the time for fully-digitized pathology has arrived.
GE-UPMC’s Omnyx Joint Venture Aims to Develop Fully-Digitized Pathology Imaging System
WHOLE-SLIDE IMAGING (WSI) SYSTEMS—also called digital slide systems or virtual microscopes—are becoming increasingly capable. The arrival of a system that can rapidly digitize large numbers of slides could have a profound effect across the pathology industry.
“While the business implications of digital pathology systems are important, a significant factor in the joint venture is the ability to develop systems to improve healthcare quality and patient safety,” explained Michael Becich, M.D., Ph.D., Chair, Dept. of Biomedical Informatics at UPMC. “There are tremendous quality and patient safety implications when you can put digital methodologies in place in the diagnostic pathway.
“A good example is diagnosing a small biopsy,” he continued. “Typically, a technologist will cut a small biopsy sample into ribbons and place 10 or 12 duplicates of the tissue on one glass slide for the pathologist to view. But what system guarantees that the pathologist actually looked at every tissue piece on the slide? The technology we are putting forward in this joint venture would ensure that the pathologist does view everything and does not overlook any tissue presented on the slide.
“Digitizing pathology slides also generates another significant benefit: increased productivity through improved work flow,” added Becich. “Digitized images allow pathologists to be more efficient because they can review the old pathology of a patient directly alongside the new pathology of that patient. Compare that with the current use of glass slides. To review the patient’s earlier pathology, it is necessary to pull the glass slides from storage or archives. This takes time, which is a critical factor for pathologists, who are already burdened with heavy workloads that continue to increase.
“The digital library of pathology images also means that a pathologist has ready access to all diagnostics images, regardless of his/her physical location,” noted Becich. “It also means that, as a pathologist calls up the patient’s latest pathology image, the digitized pathology system can automatically load and present a patient’s older pathology images from earlier treatments. This feature enhances the productivity of the pathologist, while improving patient care, since the pathologist has ready access to all of a patient’s previous pathology slides.”