CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Valerie Neff Newitt
May 2017—When the Food and Drug Administration granted permission to Philips to market its whole slide imaging system for primary diagnosis last month, it was a “big deal” of the highest order.
“Yes, this is a very big deal,” says Liron Pantanowitz, MD, a professor of pathology and biomedical informatics at the University of Pittsburgh Medical Center. “This event will provide the impetus to drive digital pathology forward for clinical use in the U.S., and allow us to catch up with our colleagues around the world who are ahead of us in their digital transformation journey.”
Eric Glassy, MD, president of the Digital Pathology Association and medical director of Affiliated Pathologists Medical Group, Rancho Dominguez, Calif., agrees. “Until last month the U.S. was the only industrialized country without an approved whole slide imaging system. Clearly, primary diagnosis is the holy grail of pathology. Now, after 15 years of very hard work, multiple clinical studies, and a great deal of collaboration, the FDA decision validates that effort and affirms that digital pathology is equivalent—not inferior—to a microscope.”
Dr. Becich
Michael Becich, MD, PhD, chairman and distinguished university professor, Department of Biomedical Informatics, University of Pittsburgh School of Medicine, is a pioneer of the digital pathology movement and has been working in this space for 20 years. He recalls when the utility of virtual microscopes was just beginning to be recognized. Only a few visionaries “believed it would ever be a reality for primary diagnostics. A lot of people thought it would just be a ‘toy’ for conference support or research,” Dr. Becich says. “They were wrong. Now it is happening. This moment is extremely satisfying.”
Dr. Becich predicts continuing emergence of digital pathology along with technology that will mine increasingly more patient information. “The crude oil of all of medicine is related to laboratory data generated on patients and their care episodes,” Dr. Becich says. “The digital framework has always been clinical tests, the numbers. Genomics is mainstream and now digital imaging, too. Those three things, together with the clinical brainpower of a pathologist and an engine to look deeply at data and find trends, will create a mammoth force for precision medicine.”
This seminal moment would not have happened were it not for progressive pathologists, championed by the Digital Pathology Association and the CAP, and the efforts of Philips and other companies. They worked in concert with a collaborative FDA team willing to meet, discuss, and eventually approve a WSI downgrade from a class III (high risk) to a class II (moderate risk) de novo device, to forge a simplified regulatory path. Philips’ IntelliSite Pathology Solution is now the first and only FDA-cleared WSI system for primary diagnosis. But experts agree Philips’ predicate device may soon be joined by follow-on devices from other manufacturers as enthusiasm and investments pick up in the wake of the de novo classification.
“Kudos to Philips for being first, and to the industry for having the fortitude to get there,” Dr. Becich says. “We will see a lot more activity in this space, including from us in Pittsburgh. Definitely.”
Glassy
Dr. Glassy says other vendors now see an easier pathway. “What was validated by the FDA was more than a single solution; it was a whole system of technology—remote viewing, diagnosing away from the microscope. This is bigger than just Philips, although they did a tremendous amount of work.”
Much of that work grew from the FDA’s concern—shared by detractors of the digital movement—that digital pathology might present a risk of misdiagnosis owing to such issues as images in poor focus, improper lining up of images, improperly scanned images, and more, says Dr. Glassy. But Philips’ diligence and the DPA’s educational efforts have shown the concerns to be largely unfounded. “There are risks with a microscope, too,” Dr. Glassy says. “We explained to the FDA the risks a pathologist has in normal practice when reviewing and reading cases on our own. We made it clear that pathologists know when an image is bad. Using a scanner will not change that. Additionally, manufacturers have improved algorithms and are making sure that scans accurately reflect what’s present on glass slides.”