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Previous Updates

We are pleased to announce some recent accomplishments of the High-throughput truthing project (HTT).

A list of all previous updates can be found on this page. Our publications and presentations are organized in this Zotero library. Our data is being shared in this GitHub repository.

The HTT project’s objective is to create a validation dataset fit for a regulatory purpose. Pursuing this objective is expected to inform regulatory frameworks and be instructive to others to develop their own validation datasets. For more detailed information about the project and/or to register as a pathologist-data-collector, please visit

The HTT project has been accepted as a project of the Truthing and Validation Workgroup of PIcc.

The HTT project was also accepted as a project of the W.H.O. International Collaboration for Cancer Classification and Research (IC3R).

  • The IC3R project is named PADEA (Pathologist Annotation Datasets for Evaluating Algorithms) to allow the effort to grow to other applications beyond TILs evaluation.
  • Link to IC3R “Projects” page.

To contact us with any questions or join our efforts: Contact Us HERE


October 2022

  • Brandon Gallas presented to the FDA Oncology Center of Excellence
    • “Developing a dataset to validate computational models that analyze digital pathology images to assess tumor-infiltrating lymphocytes (TILs) in breast cancer”
    • Link to Recording and Slides

September 2022

  • Personal Celebrations! Project managers Victor Garcia, and Kate Elfer celebrated their weddings to their significant others!

August 2022

  • Slides for our pivotal study have been received from Emory University and Stony Brook University and scanned with an Aperio AT2 DX (FDA-qualified WSI scanner)
  • Brandon Gallas presented to the Pathology Innovation Collaborative Community a Webinar on “ROC and MRMC Tutorials”
  • Brandon Gallas and Si Wen presented their work at the Joint Statistical Meeting:
    • Brandon Gallas, “Exploring Pathologist-Pathologist Agreement as a Baseline for Algorithm-Pathologist Agreement”
    • Si Wen, “Limits of Agreement for an MRMC Study”

July 2022

  • Info Sharing: One day, the public health emergency will be declared over. Here is guidance on what happens to devices that fall within pandemic enforcement policies, like WSI scanners: LINK
  • Open-Position: ORISE Fellow
    • Victor Garcia, MD, is transitioning into an FDA/CDRH/DIDSR full-time staff fellow
    • We therefore have an open ORISE Fellow position for the next year (starting 01 October 2022): Statistics and Informatics Support the Assessment of Artificial Intelligence and Machine Learning
  • Actively recruiting now – please distribute! jobDescriptionDigitalPathologyAIML-20220617-2_1.pdf (106 KB, uploaded by Katherine N Elfer 8 months 1 week ago)
  • Needed: We are looking for an FDA-cleared Scanner. We are targeting the the Aperio AT2 DX because it has a format that is open enough to be supported by several software tools and platforms.
    • One batch of pivotal study slides are in our hands!
  • Upcoming Presentations: American Statistical Association’s Joint Statistical Meeting
    • Session: Assessing Agreement and Reader Reliability in Medical Imaging Analysis (organized by Si Wen)
    • August 7th, 2022 in Washington DC
    • Link to Session Info
    • Brandon will present “Exploring ​Pathologist-Pathologist Agreement​ as a Baseline for ​ Algorithm-Pathologist Agreement​”
    • Si will present “Limits of Agreement for an MRMC Study”
    • We hope to schedule a redux of the session to be hosted by PIcc.
  • Published: Hongfei Du, Si Wen, Yufei Guo, Fang Jin, and Brandon D. Gallas, “Single reader between-cases AUC estimator with nested data,” Stat Methods Med Res, p. 9622802221111540, Jul. 2022, doi: 10.1177/09622802221111539.

June 2022

  • Re-Introduction: Phoebe Qian, ORISE Intern
    • Please see Phoebe’s Admin page
    • Phoebe is rising high school senior returning for her second summer with us!
    • Phoebe is hunting for colleges for Fall 2023 with a focus on computer science

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