Update August 2023

August 2023

New HTT project website was launched: https://didsr.github.io/HTT.home

• New HTT project website was launched: https://didsr.github.io/HTT.home

  • The NCI is decomissioning the hub where we have been sharing our work and collaborating since 2017. So sad.

  • The transition from our legacy hub group is a work in progress.

• Manuscript accepted and in production: Initial Interactions with the FDA on Developing a Validation Dataset as a Medical Device Development Tool - Journal of Pathology

  • Steven Hart (Department of Laboratory Medicine and Pathology, Mayo Clinic), et al.

  • Link will be added to our Zotero library!

• Contract awarded to Yale University to collect pathologist annotations on the eeDAP microscope system.

  • eeDAP: evaluation environment for digital and analog pathology https://www.doi.org/10.1117/1.JMI.1.3.037501

  • If you are near to Yale (New Haven, CT), email kim.blenman@yale.edu to find out more. Your time will be compensated.

July 2023

• 5-year funding award won: Burroughs Wellcome Fund Innovation in Regulatory Sciences

  • Title: “Development of optical and digital microscopy hardware, software, and statistical methods to enable assessment of computational pathology”

  • PI: Dr. Kim Blenman (Yale University)

  • co-Investigator: Dr. Brandon Gallas (FDA/CDRH/OSEL/DIDSR)

June 2023

We launched our pivotal study!

• We launched our pivotal study!

  • 5 batches of 8 slides curated - 10 ROIs per image - 400 ROIs.

  • Please share and post our information about joining the pivotal study.

  • Wiki Page.

  • One Page Recruiting Flyer for printing and posting on your bulletin board.

We launched our interactive training modules.

• We launched our interactive training modules.

  • Here is the link with information and instructions to get started on the interactive training LINK

  • There are two interactive training tests: a Feedback Test (optional: 30-60 minutes) and a Proficiency Test (required: 30-60 minutes).

  • After completing either interactive training test, performance test report will be compiled and shared with the user.

  • Here are example test reports: testReport-example-feedback.pdf and testReport-example-proficiency.pdf

  • Here is the R markdown that creates the test report: testReport.Rmd

March 2023

• Sourced and scanned 38 more H&E slides of TNBC core biopsies. Total 124!

  • We have 32 more slides that have not been scanned yet. Total 156!

Launch FDA-hosted online continuing medical education (CME) course!

• Launch FDA-hosted online continuing medical education (CME) course!

  • https://ceportal.fda.gov/

February 2023

• Presentation and proceedings paper for the SPIE Medical Imaging Conference

  • Title: Analysis of a pilot study collecting pathologist annotations for validating machine learning algorithms

  • Author: Katherine Elfer (FDA/CDRH/OSEL/DIDSR), et al.

  • Slides available on request.

January 2023

• FDA-Yale Research Collaboration Agreement fully executed.

  • This is site #3 for slide sourcing.

  • PI: Dr. Kim Blenman (Yale University)

  • PI: Dr. Brandon Gallas (FDA/CDRH/OSEL/DIDSR)

• New research assistant added to the FDA team. Emma Gardecki.

December 2022

• Poster presented at the San Antonio Breast Cancer Symposium.

  • Title: Educating pathologists in quantitating stromal tumor-infiltrating lymphocytes in breast cancer for artificial intelligence applications

  • Author: Amy Ly, (Department of Pathology, Massachusetts General Hospital), et al.

  • Poster available on request.