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.
Study Type
OBSERVATIONAL
Enrollment
3
IVD study of HER2 IHC samples: Accuracy of analysis
Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis. The study is declared Success if the lower limit of two-sided 95% exact Binomial confidence interval for I. Positive, Negative and Overall agreement with manual count will be at least 85% II. Equivocal agreement with manual count will be at least 80%
Time frame: 1 Day
IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis
Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of HER2 are related to the average agreement for between runs, between days and between systems The R\&R part of the study will be declared "Success" based on the two-level HER2/neu outcome (negative=0 \& 1+, positive=2+ \& 3+), if positive and negative average agreements will be at least 85%
Time frame: 1 Day
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