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 such value to the pathology practice that APA is interested in buying and installing the Philips system.
ONE PRIVATE PRACTICE PATHOLOGY GROUP IN MARYLAND is enthusiastic about how it can use the Philips digital pathology system to gain competitive advantage, now that the FDA has cleared this system for use in the primary diagnosis of biopsied and surgically excised tissue.
This confidence is contrary to the popular wisdom, which says that digital pathology is best suited for academic medical centers, large reference labs, and comprehensive cancer clinics.
Advanced Pathology Associates is a 15-member community pathology practice in Rockville, Md. “We began using the Phillips IntelliSite Pathology Solutions (PIPS) in April 2015,” stated Nicholas Cacciabeve, MD, APA’s Managing Partner. APA participated in the clinical study that produced the data Philips submitted to the FDA in its pre-market application.
“I was glad Philips recruited a community pathology practice to be part of its study of PIPS because I don’t think digital pathology is for academic centers only,” he noted. “It’s for everybody, including community practices.”
Advanced Pathology Associates was one of four sites that tested the PIPS for research done from October 2015 through May 2016. Philips then submitted that research to the FDA in October 2016 to support its application to use PIPS for primary diagnosis. The FDA granted that approval on April 12.
Leveling The Playing Field
Academic medical centers will certainly use the PIPS for primary diagnosis, but for Cacciabeve, the FDA approval means APA and other community practices can adopt whole slide imaging and get paid for the review and interpretation of digital surgical pathology slides prepared from biopsied and excised tissue.
“Digital pathology systems will help level the playing field between smaller pathology groups like ours and academic medical centers,” he said. “This study shows that we have the ability to transmit digital images to drive the diagnosis of specific types of tissues into the hands of experts.
“As a community practice, I don’t want to cede my ability to remain in the middle of clinical practice to academic medical centers,” he added. “Within my own group, I want to have expert pathologists who can provide real-time consultations. But at the moment, we are a relatively small group practice of 15 pathologists using glass slides.
“We’re about to begin discussions with Philips to acquire the PIPS so that we can offer our services with digital imaging to smaller hospitals that have maybe one or two pathologists,” he said. “When we do that, we can support those pathologists seamlessly into our practice through consultation with digital imaging.
The Promise Of Technology
“This means small hospitals with one or two pathologists can appear to have the same kind of sub-specialty pathology expertise as an academic medical center,” continued Cacciabeve. “That’s because the local pathologists and their referring physicians can consult in real time with us.
“The ability to share digital images means there will be no delay in the turn-around time,” he said. “That hospital can send the digital image to our specialist pathologists, who have expertise here in breast pathology, hematopathology, and other areas, and we can provide real-time consultations.
“That’s why I say that adopting digital pathology will become a necessity for community pathology groups like ours,” he explained. “It’s one reason why our practice was an early adopter in the PIPS research for the FDA submission. Being an early adopter has already given us a competitive advantage against other practices that will not adapt to digital pathology.
“We will also gain an even more significant competitive advantage when digital pathology systems start using computer algorithms to read slides,” he said. “Consider what happened with the Pap smear. Like most labs, we don’t do many conventional Paps because the technology is inferior to the new thin-prep methodology.
“That example tells me that if we don’t adapt to the newest technology in reading tissue—which is going to be a digital image with a computational pathology computer application added to it—then we are not going to remain competitive in the market- place. And we won’t be providing the best of care,” he said.
To gain that experience, Cacciabeve participated in the clinical trial Philips ran. “In our model, we have multiple pathologists at seven different hospitals, and, in this study, we used materials from two of the hospitals,” he explained. “It was important for each of our pathologists to gain expertise, including some specialty expertise, with digital pathology.
“We believe this helps level the playing field in ways that benefit our community pathology group,” noted Cacciabeve. “Traditionally, when the patient went to an academic medical center for diagnosis and treatment, there would be sub-specialists in many different fields in pathology. Depending on what biopsy or piece of tissue was taken from the patient, an expert would read it.
Suburban Pathology Group Sees Advantages With WSI
AS THE MANAGING PARTNER of Advanced Pathology Associates, Nicholas Cacciabeve, MD, views digital pathology systems as the beginning of a new era in pathology. Digital pathology systems will replace microscopes, which pathologists have used for 150 years, he said.
“There’s no question that microscopes are on the way out,” he commented. “I’ve thought so for several years now.
“It’s a big step for the FDA to clear the first system for use in the primary reading of digital images, and that’s just the beginning of what digital pathology systems can do,” noted Cacciabeve. “Digital technology will evolve to include computational pathology, which is one of the most exciting advancements to come from digital imaging.
“Today, it’s very challenging for pathologists to read cases all day long and have a continuous focus on each case,” he continued. “If you get distracted for a second or you get interrupted for something, you can miss a portion of a slide. But machines and computers don’t get interrupted. They will be able to scan the entire slide looking for abnormalities. As that happens, it will make us more efficient and improve our accuracy and precision as diagnosticians.”
“With digital pathology, we can now share a digital image seamlessly with that expert on those tough cases that need an expert to help us render a diagnosis,” he added. “It’s the same thing with consultations.
“In many hospitals, just one or two pathologists are working by themselves,” Cacciabeve explained. “Now that we have digital images, we can share those images quickly with consultant pathologists and have real-time discussions. That means there would be no delay in getting the diagnosis of the case.
“In addition, performing peer review and presenting cases at conferences can be done digitally,” he said. “For all those reasons, it’s a big advantage for a community pathology practice like ours to use a digital pathology platform.”
Of the four pathologists at APA who participated in the PIPS study, two had 20 or more years of experience and two had less than four years of experience. “It did not surprise me that the two younger pathologists adapted to the digital work-flow quickly,” he explained. “They were comfortable with the software and with viewing images on a screen.
“The more experienced pathologists were a little slower to adapt to it, at least at the beginning,” recalled Cacciabeve. “By the end of the study, all four were very comfortable with the technology and were efficient and confident in their reads.”
For the pre-market approval study, Philips installed the PIPS system at no cost. APA used it as part of the study to have the four pathologists read 500 patient cases both digitally and optically. “So, basically we had 2,000 digital reads,” he said. “That was valuable experience for us. Then once the study was over, they removed the equipment.
“One reason I wanted to participate in the project is I’m a strong believer that digital pathology is maturing rapidly,” he said. “I saw it as a way to get our pathologists some experience using it in a safe, controlled setting.
“That’s just what we got: 2,000 digital reads under somewhat real-life conditions,” he added. “They read the slides as if it was the first time they were seeing the slides. We then submitted the diagnoses that were matched against a control standard, which was the original microscopic diagnosis done at least a year earlier.
“Four of our pathologists acquired valuable experience over the nine months of the research study (April 2015 to February 2016),” he said.
“We were assigned to read breast cases, gastric cases, respiratory cases from the lungs and larynx, and the oral cavity,” he explained. “These 2,000 reads gave us experience with those organ sets.
Pathology Is A Business
“When you think about it, medicine is a business and pathology is a business,” he added. “And someone said once that if you’re not participating in the business, you’re a victim of the business. Look at how clinical laboratories consolidated rapidly in the 1990s and look at how anatomic pathology groups are consolidating rapidly now.
“That consolidation suggests that the older model of one- or two-person practices will go by the wayside,” concluded Cacciabeve. “At the same time, the digitalization of pathology will completely change the way we do the work today.”
Contact Nicholas Cacciabeve, MD, at firstname.lastname@example.org or 240-826-6096.