While pathologists in the U.S. wait—and wait—for the Food and Drug Administration to move toward approving whole slide imaging for primary diagnosis in U.S. laboratories, their neighbors to the north are already celebrating.
That’s because the first two whole slide imaging systems—Leica Biosystems’ Aperio ePathology solution and GE Healthcare’s Omnyx Integrated Digital Pathology (the latter developed in partnership with the University of Pittsburgh Medical Center)—have just been cleared for routine diagnostic use in Canada. The Omnyx IDP and ePathology AT Turbo and CS ScanScope systems have also received the European Union’s CE Mark.
This while “the FDA is still trying to sort out what type of a study design they’ll accept before they would consider approving devices” like those, says Andrew Evans, MD, PhD, associate professor of pathology at University Health Network, Toronto, and associate professor in the Department of Laboratory Medicine and Pathobiology at the University of Toronto.
What’s driving this regulatory disparity? A host of factors. First among them: Demographics. Canada’s area is larger than that of the United States, while its population is smaller than that of California. The Canadian government therefore has every incentive to invest in technology that would improve access and care for patients living in remote areas.
Says Dr. Evans, who served as principal investigator for a clinical trial of the Omnyx IDP system at UHN: “There’s been tremendous interest from specific groups in Canada in using these devices for diagnostic work. It makes sense because Canada is a huge country with a relatively small population, most of which is centered within two hours’ drive of the U.S. border. But still there are many communities scattered over a huge territory.” On top of that, he says, is a growing movement toward developing subspecialty pathology centers in Canada. “As a result, you end up having glass slides moving great distances in order for consultants with subspecialty expertise to review them.” So it makes sense to try, through the use of digital technology, to reduce delays and eliminate the risk of loss of or damage to slides associated with shipment, he says.
Second, says Leica Biosystems’ chief medical officer and past CAP president Jared Schwartz, MD, PhD, a rash of highly publicized quality control incidents in Canadian pathology laboratories a few years ago has led the country’s provincial governments to explore and invest in new technologies—such as telemedicine. “For a number of years, laboratories in Canada have slowly but surely been increasing the number of cases that they have been doing utilizing this technology,” he says. “As you would expect, they’ve gotten more confident and seen that it works. They have aggressively, but with great professionalism, adopted this technology.”
By way of example: Canadian pathologist Bernard Têtu, MD, has been working since 2004 on the Québec
Telepathology Project, an initiative that aims to increase telepathology adoption for frozen sections and consultations in eastern Québec
. Sponsored by the province’s Ministry of Health and Social Services, and aided by an existing dedicated information network that links all of the province’s hospitals, the project implemented telepathology services in 21 hospitals, of which six have no pathology laboratory of their own. Right away, Dr. Têtu, professor of pathology at Centre Hospitalier Universitaire de Québec, found that rallying support for the project among the participating hospitals would not be difficult.
“We really wanted to have a project that was a priority for both pathologists and administrators,” he explains. “So we did a survey. The surgeons were very interested because in some remote hospitals with no pathologists, many times they had to transfer patients. Or many times the pathologists were working alone and wanted to get quick opinions from colleagues. And administrators were interested because of the cost. When there is no pathologist, you have to pay for transportation and so on, and the government has to pay for patient transfer to other hospitals.”
The project has been so successful that the Québec
health ministry has asked Dr. Têtu to expand it to other hospitals in the province. Then, too, the Canadian Association of Pathologists asked him last year to develop guidelines for implementing a telepathology network in the country. (That document, “Guidelines for Establishing a Telepathology Service for Anatomic Pathology Using Whole Slide Imaging,” is available online.)
Will Health Canada’s approval of the Leica and GE devices have any bearing on the FDA’s activities regarding whole slide imaging? “It may raise the frustration levels of pathologists in the United States,” jokes Michael Montalto, PhD, Omnyx senior vice president for clinical and medical affairs. But, in his view, that’s about it: “I don’t think it will sway the FDA’s process.”
“I don’t believe that this will impact the way the FDA does its job,” agrees Dr. Schwartz. Think, he says, about the number of new technologies facing the FDA: whole genome sequencing, direct-to-consumer genomics, all kinds of new biomarkers. “And we’re just talking about pathology. You’ve got an explosion of technology from so many different areas. They have only a certain number of staff and resources, and they have to set their priorities. At some point, I don’t know when, the FDA will put whole slide imaging on its priority list.”
In the meantime, pathologists in the U.S. can take consolation in that while they wait, Canada and other countries (such as Sweden) where whole slide imaging has already been approved for primary diagnosis “will definitely be producing peer-reviewed articles” about the technology, Dr. Schwartz points out. “This will be an opportunity for American pathologists to learn from our colleagues who are able to take the lead. It’s important for us to pay attention to what’s going on in these other countries and learn from them, because they’re on a learning curve. Even after approval, there are still adoption issues. It took my father, I think, a decade to learn how to go from a stick shift to automatic.”
At least one vendor is hoping that Health Canada’s approval will, if nothing else, help convince pathologists in the U.S. of the technology’s safety and efficacy. “We’ve demonstrated that this technology is very safe for routine work in Canada, with very few exceptions,” says Luigi Gentile, executive director of GE Healthcare’s Pathology Innovation Centre of Excellence. “It really is a milestone in the acceptance of this technology.”
Anne Ford is a writer in Evanston, Ill.