Journal Article
. 2018 May; 142(11):1383-1387.
doi: 10.5858/arpa.2017-0496-CP.

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  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  Liron Pantanowitz 1 
Affiliations
  • PMID: 29708429
  •     28 citations

Abstract

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.

Innovation in Transplantation: The Digital Era.
Albino Eccher, Matteo Brunelli, +3 authors, Aldo Scarpa.
J Pathol Inform, 2018 Oct 09; 9. PMID: 30294502    Free PMC article.
Computational pathology definitions, best practices, and recommendations for regulatory guidance: a white paper from the Digital Pathology Association.
Esther Abels, Liron Pantanowitz, +9 authors, Cleopatra Kozlowski.
J Pathol, 2019 Jul 30; 249(3). PMID: 31355445    Free PMC article.
Review.
Artificial intelligence in clinical and genomic diagnostics.
Raquel Dias, Ali Torkamani.
Genome Med, 2019 Nov 21; 11(1). PMID: 31744524    Free PMC article.
Review.
Next generation diagnostic pathology: use of digital pathology and artificial intelligence tools to augment a pathological diagnosis.
Anil V Parwani.
Diagn Pathol, 2019 Dec 29; 14(1). PMID: 31881972    Free PMC article.
Video compression to support the expansion of whole-slide imaging into cytology.
Mark D Zarella, Jennifer Jakubowski.
J Med Imaging (Bellingham), 2020 Jan 01; 6(4). PMID: 31890747    Free PMC article.
Whole slide imaging compared with light microscopy for primary diagnosis in surgical neuropathology: a validation study.
Ali Alassiri, Amna Almutrafi, +5 authors, Walid Khalbuss.
Ann Saudi Med, 2020 Feb 07; 40(1). PMID: 32026707    Free PMC article.
Validation of Image Quality and Diagnostic Accuracy Using a Mobile Phone Camera Microscope Adaptor Compared With Glass Slide Review in Teledermatopathology.
Caroline W Laggis, Elizabeth E Bailey, +5 authors, Carrie Kovarik.
Am J Dermatopathol, 2019 Oct 22; 42(5). PMID: 31633596    Free PMC article.
Histologic Classification and Molecular Signature of Polymorphous Adenocarcinoma (PAC) and Cribriform Adenocarcinoma of Salivary Gland (CASG): An International Interobserver Study.
Bin Xu, Andrea L Barbieri, +26 authors, Nora Katabi.
Am J Surg Pathol, 2020 Jan 10; 44(4). PMID: 31917707    Free PMC article.
Digital pathology and computational image analysis in nephropathology.
Laura Barisoni, Kyle J Lafata, +2 authors, Ulysses G J Balis.
Nat Rev Nephrol, 2020 Aug 28; 16(11). PMID: 32848206    Free PMC article.
Review.
Twenty Years of Digital Pathology: An Overview of the Road Travelled, What is on the Horizon, and the Emergence of Vendor-Neutral Archives.
Liron Pantanowitz, Ashish Sharma, +3 authors, Joel Saltz.
J Pathol Inform, 2019 Jan 05; 9. PMID: 30607307    Free PMC article.
Review.
Developing and Preliminary Validating an Automatic Cell Classification System for Bone Marrow Smears: a Pilot Study.
Hong Jin, Xinyan Fu, +15 authors, Jun Zhang.
J Med Syst, 2020 Sep 08; 44(10). PMID: 32894360    Free PMC article.
Artificial intelligence (AI) and big data in cancer and precision oncology.
Zodwa Dlamini, Flavia Zita Francies, Rodney Hull, Rahaba Marima.
Comput Struct Biotechnol J, 2020 Oct 01; 18. PMID: 32994889    Free PMC article.
Review.
Display Characteristics and Their Impact on Digital Pathology: A Current Review of Pathologists' Future "Microscope".
Jacob T Abel, Peter Ouillette, +7 authors, David S McClintock.
J Pathol Inform, 2020 Oct 13; 11. PMID: 33042602    Free PMC article.
Review.
LibMI: An Open Source Library for Efficient Histopathological Image Processing.
Yuxin Dong, Pargorn Puttapirat, +2 authors, Chen Li.
J Pathol Inform, 2020 Oct 13; 11. PMID: 33042605    Free PMC article.
Whole Slide Imaging (WSI) in Pathology: Current Perspectives and Future Directions.
Neeta Kumar, Ruchika Gupta, Sanjay Gupta.
J Digit Imaging, 2020 May 30; 33(4). PMID: 32468487    Free PMC article.
Review.
SITC cancer immunotherapy resource document: a compass in the land of biomarker discovery.
Siwen Hu-Lieskovan, Srabani Bhaumik, +14 authors, Holden T Maecker.
J Immunother Cancer, 2020 Dec 04; 8(2). PMID: 33268350    Free PMC article.
(Re) Defining the High-Power Field for Digital Pathology.
David Kim, Liron Pantanowitz, +6 authors, Matthew G Hanna.
J Pathol Inform, 2020 Dec 22; 11. PMID: 33343994    Free PMC article.
Deep learning-enabled medical computer vision.
Andre Esteva, Katherine Chou, +7 authors, Richard Socher.
NPJ Digit Med, 2021 Jan 10; 4(1). PMID: 33420381    Free PMC article.
Review.
Artificial intelligence and computational pathology.
Miao Cui, David Y Zhang.
Lab Invest, 2021 Jan 18; 101(4). PMID: 33454724    Free PMC article.
Review.
Harnessing non-destructive 3D pathology.
Jonathan T C Liu, Adam K Glaser, +4 authors, Anant Madabhushi.
Nat Biomed Eng, 2021 Feb 17; 5(3). PMID: 33589781    Free PMC article.
Review.
Rapid Validation of Whole-Slide Imaging for Primary Histopathology Diagnosis.
Megan I Samuelson, Stephanie J Chen, +5 authors, Anand Rajan K D.
Am J Clin Pathol, 2021 Jan 30; 155(5). PMID: 33511392    Free PMC article.
Multiplexed Immunohistochemistry and Digital Pathology as the Foundation for Next-Generation Pathology in Melanoma: Methodological Comparison and Future Clinical Applications.
Yannick Van Herck, Asier Antoranz, +4 authors, Francesca Maria Bosisio.
Front Oncol, 2021 Apr 16; 11. PMID: 33854972    Free PMC article.
Review.
Integrating the Health-care Enterprise Pathology and Laboratory Medicine Guideline for Digital Pathology Interoperability.
Rajesh C Dash, Nicholas Jones, +7 authors, François Macary.
J Pathol Inform, 2021 Jul 06; 12. PMID: 34221632    Free PMC article.
Dissecting the Business Case for Adoption and Implementation of Digital Pathology: A White Paper from the Digital Pathology Association.
Giovanni Lujan, Jennifer C Quigley, +16 authors, Doug Bowman.
J Pathol Inform, 2021 Jul 06; 12. PMID: 34221633    Free PMC article.
Diagnostic concordance and discordance in digital pathology: a systematic review and meta-analysis.
Ayesha S Azam, Islam M Miligy, +4 authors, David R J Snead.
J Clin Pathol, 2020 Sep 17; 74(7). PMID: 32934103    Free PMC article.
Systematic Review.
Remote Reporting During a Pandemic Using Digital Pathology Solution: Experience from a Tertiary Care Cancer Center.
Veena Ramaswamy, B N Tejaswini, Sowmya B Uthaiah.
J Pathol Inform, 2021 Jul 17; 12. PMID: 34267985    Free PMC article.
Looking for more reliable biomarkers in breast cancer: Comparison between routine methods and RT-qPCR.
Emanuele Caselli, Cristina Pelliccia, +10 authors, Angelo Sidoni.
PLoS One, 2021 Sep 24; 16(9). PMID: 34555047    Free PMC article.
More scanning, but not zooming, is associated with diagnostic accuracy in evaluating digital breast pathology slides.
Trafton Drew, Mark Lavelle, +4 authors, Joann G Elmore.
J Vis, 2021 Oct 13; 21(11). PMID: 34636845    Free PMC article.