All Times EDT
Keywords: Analytical studies, in vitro tests, clinical study, IHC
Immunohistochemistry (IHC) assays utilize immunostaining which involves the process of selectively identifying antigens (proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues. Immunohistochemical staining is widely used in the diagnosis of abnormal cells such as those found in cancerous tumors. In evaluating the staining slides, a trained pathologist/reader provide either a binary determination or an ordinal scoring based on the staining intensity, percentage of cells stained, and sometimes staining localization and patterns, in applications such as cancer tumors. IHC assays have been used as a companion diagnostic for safe and effective use of a corresponding therapeutic product. This session discusses the statistical issues and challenges in analytical and clinical validation studies for evaluation of such assays in the context of companion diagnostic device.