From some of the top digital pathology thought leaders: FDA Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised

Andrew J. Evans, Thomas W. Bauer, Marilyn M. Bui, Toby C. Cornish, Helena Duncan, Eric F. Glassy, Jason Hipp, Robert S. McGee, Doug Murphy, Charles Myers, Dennis G. O'Neill, Anil V. Parwani, B. Alan Rampy, Mohamed E. Salama, and Liron Pantanowitz (2018) US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised. Archives of Pathology & Laboratory Medicine In-Press.

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US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised

Andrew J. Evans, MD, PhD; Thomas W. Bauer, MD, PhD; Marilyn M. Bui, MD, PhD; Toby C. Cornish, MD, PhD; Helena Duncan, BBA, MJ; Eric F. Glassy, MD; Jason Hipp, MD, PhD; Robert S. McGee, MD, PhD; Doug Murphy, MT (ASCP); Charles Myers, MD; Dennis G. O'Neill, MD; Anil V. Parwani, MD, PhD; B. Alan Rampy, DO, PhD; Mohamed E. Salama, MD; Liron Pantanowitz, MD

From the Laboratory Medicine Program, Department of Pathology, University Health Network, Toronto, Ontario, Canada (Dr Evans); the Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, New York, New York (Dr Bauer); the Department of Anatomic Pathology, H. Lee Moffitt Cancer Center, Tampa, Florida (Dr Bui); the Department of Pathology, University of Colorado Denver, Aurora (Dr Cornish);

Corresponding author: Andrew J. Evans, MD, PhD, Department of Pathology, University Health Network, Toronto General Hospital, Eaton Wing, Room E11-223, 200 Elizabeth St, Toronto, ON M5G 2C4, Canada (email: andrew.evans@uhn.ca).

Dr Bauer is a consultant to Leica Biosystems. Dr Cornish is on the Pathology Imaging Advisory Board with Leica Biosystems and has US patent 9,214,019, “Method and System to Digitize Pathology Slides in a Stepwise Fashion for Review.” Dr Hipp is a contractor for Google. Dr Pantanowitz is a consultant for Hamamatsu and is on the medical advisory board for Leica Biosystems. The other authors have no relevant financial interest in the products or companies described in this article.

Ms Duncan and Mr Murphy are employees of the College of American Pathologists.

April 12, 2017, marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.