Description of use

The p53 Quantifier is intended as an aid to the pathologist in the detection and counting of tumor cells in digital images of formalin-fixed, paraffin-embedded invasive ductal and lobular breast cancer tissue which underwent immunohistochemical (IHC) staining against p53 protein. It detects tumor cells automatically, classifies them into positively and negatively stained tumor cells and gives the clinically relevant score. The classification is visualized per cell for the pathologist within a region of interest (ROI) that was manually outlined and assessed as suitable for analysis by the pathologist. The pathologist has to review the results of the p53 Quantifier and is responsible for the final diagnosis that is recorded manually in the patient case record. p53 as biomarker, currently RUO, is an ideal add-on to our Breast-IHC product suite (CE-IVD) for breast cancer.