The Friends of Cancer Research has initiated the Digital and Computational Pathology Tool Harmonization (Digital PATH) Project, a research endeavor focused on enhancing biomarker assessment consistency across computational pathology platforms. The project aims to pinpoint factors contributing to variability in biomarker assessment, propose alignment strategies in the field, and offer insights to shape regulatory processes.
The nonprofit has brought together diverse groups, including algorithm developers, patient advocates, government officials, pathologists, and drug developers, to collaboratively address variability in biomarker assessment. Partners in the Digital PATH Project include 4D Path, Amgen, AstraZeneca, Bristol Myers Squibb, EMD Serono, GlaxoSmithKline, Indica Labs, Johnson & Johnson Innovative Medicine, Loxo@Lilly, Lunit, Massachusetts General Hospital, MD Anderson Cancer Center, Merck, National Cancer Institute, Nucleai, PathAI, Patient Advocates, Roche Diagnostics, Sanofi, Tempus AI, the University of North Carolina, Verily, ZAS Hospitals Antwerp, and the US Food and Drug Administration.
Initially focusing on HER2 biomarkers, the project will assess concordance of HER2 expression measurements in breast cancer samples across testing platforms. It will identify factors contributing to variability and utilize samples from the pathology department at ZAS Hospitals in Antwerp, Belgium.
CEO Jeff Allen emphasized the increasing integration of artificial intelligence tools in healthcare, particularly in digital and computational pathology, and highlighted the collaborative research partnership’s role in informing future policies for the optimal regulation and utilization of these advanced technologies. Friends of Cancer Research has previously led similar projects examining differences between genomic testing platforms assessing complex biomarkers like homologous recombination deficiency (HRD) and tumor mutational burden (TMB).