Road to Commercializing an Image Analysis-based Immuno-oncology Diagnostic*
Thomas Nifong, MD
Executive Vice President Predictive Tests, Definiens Inc.
Immunohistochemistry (IHC) is an essential technology for measuring biomarkers in cancer patients to determine prognosis and predict therapeutic responses. The interpretation of IHC is typically accomplished by manually scoring cells based on relative staining intensity, and calculating a semiquantitative score. Classic IHC-based biomarkers include ER, PR, Her2, and Ki-67 in breast cancer. Although IHC is widely used, it still suffers from lack of consensus in pathologist interpretations. To combat that deficiency, computer assisted companion algorithms have been introduced as an objective, quantitative method to improve scoring reproducibility, and several have been FDA cleared based on their substantial equivalence to manual scoring.
With the current understanding of the immunologic role in oncology, biomarker profiling has shifted from exclusively focusing on drug targets in tumor cells to a more complex analysis including the tumor microenvironment to understand prognosis and predict response to immunotherapies. Image analysis is an essential tool for extracting contextual data between immunohistochemically stained tumor and immune cells that enables the pathologist to provide deeper insights into the individual disease. Mining of the resultant data has produced new biomarker signatures that cannot be reproduced manually by a pathologist. We are thus transitioning image analysis from supportive companion algorithms to integral components of prognostic and predictive scores. Translating complex image analysis-based biomarkers from discovery to pivotal drug trials and clinical diagnostics presents technical, regulatory, and commercial challenges.
In this presentation we discuss the road to commercializing an image analysis-based immuno-oncology diagnostic for predicting response to therapeutics. We describe how we are implementing our software into clinical products and preparing the landscape for regulated companion diagnostics. We show how Definiens is partnering with pharmaceutical and diagnostics companies to create a system that is robust and deployable to meet the regulatory and commercial challenges and bring Tissue Phenomics discoveries to patients.