CUSTOMIZED RESEARCH STUDIES

We start with a pilot study, designed to identify the feasibility of using the antibody for immunohistochemistry. The pilot study is planned in collaboration with the client. We make recommendations based on the information from the client about the antibody and its history.

For example, investigators provide PhenoPath with a monoclonal or polyclonal antibody for evaluation. A cell line that expresses the antigen and cells that do not express the antigen are selected and cell pellets, either frozen or formalin-fixed and paraffin embedded, are prepared and tested by immunohistochemistry. Once a staining protocol is developed the antibody is then tested on a limited number of the targeted tumor tissues with further optimization on tissue where indicated. Following the pilot study, antibodies are tested on panels of tumor and normal human tissue in order to assess sensitivity and specificity. All of the tissues are evaluated for extent of tissue staining (percentage of tumor), the intensity of staining, and the localization both in the tumor and in individual cells (membranous, nuclear, cytoplasmic).

All projects are individually tailored to the specific goals of the investigator. For instance, with the advent of new therapies directed at molecular targets, such as HER2 for breast cancer, specialized diagnostic tests are needed in order to determine individual patient therapy. PhenoPath can help develop the diagnostic tests needed for identification of these unique cancer antigens.