Histopathology: A canvas and landscape of disease in drug and diagnostic development

Abstract

The aims of diagnostic and therapeutic development are to accurately diagnose and cure disease, respectively. For the past century and a half, histopathology-the microscopic examination of cells and tissues-has been considered a "gold standard" for the diagnosis of many diseases. As an introduction to this volume on molecular histopathology and tissue biomarkers in drug and diagnostic development, I explore the relationship between histopathology and the nature of disease itself. A lack of agreement on the meaning of "disease" has led to widespread and indiscriminate use of the term. Here, I propose that the term "disease" be reserved for conditions where there exists some knowledge of alterations in cells or their products that participate in cause-effect relationships in lesional (diseased) tissue. This is a definition that simultaneously lends legitimacy to the term's use while enabling revision and testing of hypotheses based on rapidly emerging scientific knowledge. With this perspective, histopathology, as a preferred means to visualize and depict the cellular events that constitute disease as it impacts tissue structure and function, will remain essential to develop new diagnostic tests and targeted therapies for the foreseeable future.