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HTT update 20201023

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HTT data-collection relaunch and project update. Help Needed.

Update: October 23, 2020

Dear all,

We are pleased to announce some recent accomplishments of the High-throughput truthing project (HTT) and request your assistance to maintain progress (HELP!).

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

HELP! We need more pathologist annotations and physical slides to complete our pilot study.

Once the pandemic subsides, we are also hoping to recruit host sites for collecting microscope-mode data using the eeDAP platform (LINK to eeDAP manuscript, Link to eeDAP GitHub repo).

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


  • Manuscript submitted and in pre-publication with the first results to the Journal of Pathology Informatics!
    • Poster presentation: “A Pathologist-Annotated Dataset for Validating AI/ML: A Project Description and Pilot Study”, Link
    • Pre-Publication Link:
  • We have developed pilot data and data aggregation pipelines.
  • We have made progress on the development of statistical analysis plans. For a related presentation, click HERE.
  • We have submitted an inquiry to the FDA Medical Device Development Tool program, received feedback, and are drafting our response and full MDDT qualification plan.
  • We have developed RCA (Research Collaboration Agreement- templates, for the template, click HERE. (
  • We have submitted an internal funding proposal to the FDA Office of Women’s Health.
  • FDA has recruited Katherine Elfer, a NCI-FDA Cancer Prevention Fellowship Program / Interagency Oncology Task Force fellow, to work on this project.
  • Thanks for all your support with spreading the word about what we do! For more details or questions, contact Katherine Elfer ( and Brandon Gallas (

    The HTT Leadership Team,

    Brandon Gallas, FDA; Project Lead

    Katherine Elfer, FDA, Project Coordinator


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