Thursday, February 1, 2024

FOCR Launches Digital Pathology Harmonization Project

Friends of Cancer Research (FOCR) launches a major new initiative called PATH - Digital and Computational Pathology Tool Harmonization Project - Digital PATH.   (Harmonization projects of diverse types have been a significant focus of FOCR).

See the home page here, which links to white papers and one pagers.  Harmonization of dig path (AI?) readings of Her2 slides are an early target.  Here's their 27pp dig path white paper from September 2023.

For the dig path home page:

They write, The Digital and Computational Pathology Tool Harmonization (Digital PATH) Project, led by Friends of Cancer Research (Friends), supports robust development of digital and computational pathology platforms for use in oncology drug development and is currently assessing variability in biomarker measurements across platform developers to encourage alignment. Stay up to date with #AIOncology.

I've clipped part of the press release below:

Washington, DC – February 1st, 2024 - Friends of Cancer Research (Friends) is excited to announce the launch of a new research partnership, Digital and Computational Pathology Tool Harmonization (Digital PATH) Project. This project will identify factors that may contribute to variability in biomarker assessment across computational pathology platforms, propose areas for alignment in the field, and provide insights for shaping regulatory processes. 

The igital PATH Project is guided by extensive collaboration and aims to enhance the use of these computational digital pathology platforms and improve patient care.  

“As artificial intelligence tools increasingly become part of healthcare, their use in digital and computational pathology open remarkable opportunities for enhanced diagnostic insights,” said Jeff Allen, President & CEO of Friends. “This new collaborative research partnership will help inform future policies toward optimal regulation and utilization of these advanced technologies.” 

During this research partnership, human epidermal growth factor receptor 2 (HER2) computational pathology algorithm developers will collect and analyze data to assess concordance of HER2 measurement from breast cancer samples across platforms and identify factors contributing to variability. HER2 is a biomarker with novel opportunities in breast cancer treatment and expanded relevance in other cancer types with the emergence of a new class of drugs called antibody drug conjugates. Samples are being provided by collaborators at the Department of Pathology, ZAS Hospitals in Antwerp, Belgium.

“What is currently largely unknown and crucial for incorporation of AI-tools in our trial- and daily-practices is the comparability and performance of different AI-platforms on the same set of slides," said Roberto Salgado, Breast Pathologist, ZAS Hospitals. "This study will provide important insights to the community, including regulatory bodies and industry, about the capabilities of AI tools and their application in patient care, ultimately aiming to ensure the best possible care and outcomes for patients.”

The Digital PATH Project will evaluate the implementation of several proposals included in our 2023 white paper released at the public meeting, Future in Focus: Digital Pathology in Oncology Drug Development. 

To learn more about the project, please visit: 

Project Partners 

Digital PATH Project Partners: Friends is proud to partner with 4D Path Inc., Amgen, AstraZeneca, Bristol Myers Squibb, EMD Serono, Inc., the U.S. Food and Drug Administration (FDA), GSK,  Indica Labs, Johnson and Johnson Innovative Medicine, Loxo@Lilly, Lunit, Massachusetts General Hospital, MD Anderson Cancer Center, Merck and Co., National Cancer Institute (NCI), Nucleai, PathAI, Patient Advocates, Roche Diagnostics, Sanofi, Tempus AI, Inc., University of North Carolina, Verily, and ZAS Hospitals Antwerp.