Clinical-Grade Validation of an Autofluorescence Virtual Staining System With Human Experts and a Deep Learning System for Prostate Cancer.

Journal: Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc
PMID:

Abstract

The tissue diagnosis of adenocarcinoma and intraductal carcinoma of the prostate includes Gleason grading of tumor morphology on the hematoxylin and eosin stain and immunohistochemistry markers on the prostatic intraepithelial neoplasia-4 stain (CK5/6, P63, and AMACR). In this work, we create an automated system for producing both virtual hematoxylin and eosin and prostatic intraepithelial neoplasia-4 immunohistochemistry stains from unstained prostate tissue using a high-throughput hyperspectral fluorescence microscope and artificial intelligence and machine learning. We demonstrate that the virtual stainer models can produce high-quality images suitable for diagnosis by genitourinary pathologists. Specifically, we validate our system through extensive human review and computational analysis, using a previously validated Gleason scoring model, and an expert panel, on a large data set of test slides. This study extends our previous work on virtual staining from autofluorescence, demonstrates the clinical utility of this technology for prostate cancer, and exemplifies a rigorous standard of qualitative and quantitative evaluation for digital pathology.

Authors

  • Pok Fai Wong
    Department of Pathology, Yale School of Medicine, New Haven, Connecticut.
  • Carson McNeil
    Verily Life Sciences LLC, South San Francisco, California. Electronic address: cmcneil@verily.com.
  • Yang Wang
    Department of General Surgery The First People's Hospital of Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology Kunming China.
  • Jack Paparian
    Verily Life Sciences LLC, San Francisco, California.
  • Charles Santori
    Verily Life Sciences LLC, South San Francisco, California.
  • Michael Gutierrez
    Verily Life Sciences LLC, South San Francisco, California.
  • Andrew Homyk
    Verily Life Sciences LLC, South San Francisco, California.
  • Kunal Nagpal
    Google Health, Palo Alto, CA USA.
  • Tiam Jaroensri
    Google LLC, Mountain View, California.
  • Ellery Wulczyn
    Google Health, Palo Alto, CA USA.
  • Tadayuki Yoshitake
    Verily Life Sciences LLC, San Francisco, California.
  • Julia Sigman
    Verily Life Sciences LLC, San Francisco, California.
  • David F Steiner
    Google Health, Palo Alto, CA USA.
  • Sudha Rao
    Verily Life Sciences LLC, San Francisco, California.
  • Po-Hsuan Cameron Chen
    Google LLC, Mountain View, California.
  • Luke Restorick
    Leica Biosystems, Nussloch, Germany.
  • Jonathan Roy
    Leica Biosystems, Nussloch, Germany.
  • Peter Cimermančič
    Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, California, USA.