David Fabrizio

David Fabrizio, PhD is Vice President of Clinical Development and Medical Affairs at Foundation Medicine, where he has been instrumental in developing and validating FoundationOne CDx as the first FDA-approved comprehensive genomic profiling assay covering all four major biomarker categories: gene alterations, MSI, TMB, and genomic loss of heterozygosity (gLOH). He led the analytical and clinical validation studies that enabled FDA approval of FoundationOne CDx as a companion diagnostic for multiple targeted therapies and as the reference method for TMB-high determination across solid tumors. Fabrizio's work on harmonizing TMB measurement across platforms has been central to the Blueprint TMB harmonization effort, and he has published extensively on MSI detection concordance between PCR-based and NGS-based methods. His scientific contributions have directly shaped how precision oncology biomarkers are standardized and integrated into clinical decision-making globally.