Breast Cancer Clinical Trial
Official title:
Concordance Study of Her2 Expression Level in Breast Cancer Tissues
The purpose of the study is the identification and quantification of protein expression
level in breast cancer tissues.
The imaging system is intended for diagnostic use as an aid to the pathologist in the
detection, counting and classifying her2 immunohistochemical (IHC) stained samples.
The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides. ;
Observational Model: Cohort, Time Perspective: Retrospective
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