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FDA action lends force to digital pathology

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April 25, 2014—The latest Food and Drug Administration grant of 510(k) clearance for a digital pathology tool could reassure pathologists that reading and analyzing slides on a computer monitor will yield results resembling those achieved when viewing traditional glass slides.

The agency in April cleared the Manual Read of the Digital HER2 Application made by Omnyx, a joint venture of GE Healthcare and UPMC, the Pittsburgh-based health system and insurer. The device is based on the Omnyx Integrated Digital Pathology System.

“Pathologists will see this as validation that they can make similar decisions when using this system versus glass. … This is a stepping stone toward more and more adoption,” says Jonhan Ho, MD, director of dermatopathology at UPMC. Dr. Ho sits on the Omnyx board of advisors and has a personal consulting agreement with the company.

“The real reason I’m interested in this technology is to improve the way I work,” he says. “I read 500 or so slides a day. Basically, I have to be in a specific room fairly close to the lab if I want to read my cases. But I have meetings all over the city and all over the country, and it’s very difficult for me to take care of my patients when I’m not near the microscope. This technology basically breaks the physical connection between me and my microscope. I can look at my cases anywhere and deliver patient care regardless of my location.”

In one example of the tool’s potentially broad application, the Omnyx device lets pathologists use microscopy images displayed on a computer monitor to detect and semiquantitatively measure HER2/neu in formalin-fixed, paraffin-embedded normal and neoplastic tissue that has been immunohistochemically stained for HER2 receptors with the Dako HercepTest. The Omnyx results can be used to help manage and predict therapy outcomes in breast cancer, but the device cannot be marketed for use as a general diagnostic tool.

Omnyx’s is not the first such device to win the FDA’s approval. The agency also gave the nod to similar tools from Aperio Technologies, Ventana Medical Systems, and Royal Philips.

Another advantage these digital tools offer pathologists is the capacity to offer quantitative analysis to help guide treatment, Dr. Ho adds, offering meteorology as an analogy.

“If you ask someone what the weather’s like, they can tell you it’s really warm, or to wear a sweater, that it’s breezy or that you should wear a light jacket,” he explains. “But they can’t tell you that it’s 52 degrees and the atmospheric pressure is this, or the wind chill is that. We in pathology are stuck in this ‘it’s warm’ or ‘it’s breezy’ phase from the prethermometer age. Digital pathology will give us new tools to measure things that we could never measure before. It will be much more precise than we ever have been previously. The market is demanding this of pathologists.”

The ability to easily share cases digitally also could help ensure that close cases get called correctly, Dr. Ho says.

“With a difficult breast cancer case, now it can be read remotely by anyone. So the idea is that you could get it read by the best experts in breast pathology, if you had a case you weren’t certain about,” he says. “That extends past HER2 and past breast pathology. It means you can get the right case to the right pathologist at the right time. ”

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