Abstract
Breast cancer is a leading malignant disease in women worldwide, although its pathology is visually localised. Currently, it has been proven that the parameters of molecular genetic biomarkers, including oncoprotein HER2, proliferation markers Ki-67, oestrogen receptors ER, and progesterone receptors PgR, are associated with breast carcinogenesis and are a reflection of the biological aggression of the tumour. The significance of these biomarkers in signalling pathways and genetic mechanisms of carcinogenesis has been described, as well as the relationship between the expression levels of each biomarker and the tumour response to appropriate therapy. The primary antibody that imparts specificity to IHC is based on the monoclonal antibodies (mAbs) as the main immunoreagent that enables reliable identification of breast cancer cells. The most commonly used antibodies to molecular biomarkers for IHC were determined in accordance with indicators of laboratory use and efficiency (pass rate) of HER2, Ki-67, ER, PgR assessments in the NordiQC breast cancer module. The discovery of the complete structure of these biomarkers and the design of their domains and subdomains by genetic engineering methods enable the synthesis of effective monoclonal antibodies. Quantitative indicators of the expression levels of tumour biomarkers of breast cancer were determined using mAb, depending on epitope specificity and affinity.
Highlights
Breast cancer is the most diagnosed cancer among women in many countries
The most widely used monoclonal antibodies (mAbs) for ImmunoHistochemical Analysis (IHC) diagnosis of breast cancer involving molecular markers HER2, Ki-67, ER, and progesterone receptors (PgR) were determined in accordance with the Nordic Immunohistochemical Quality Control (NordiQC) assessments
It has been proven that the parameters of molecular genetic markers, such as oncoprotein HER2, proliferation markers Ki-67, oestrogen receptors ER, and progesterone receptors PgR, are associated with breast carcinogenesis and are a reflection of the biological aggression of the tumour
Summary
Breast cancer is the most diagnosed cancer among women in many countries. In 2020, new cases of breast cancer were detected, accounting for 24.5% of all 9 227 484 registered cases of cancer in women worldwide. 2. STRUCTURE, FUNCTION, AND EXPRESSION OF MOLECULAR BIOLOGICAL MARKERS FOR IMMUNOHISTOCHEMICAL DIAGNOSIS OF BREAST CANCER. In the epithelium of the mammary gland, a low expression of ER and PgR is observed (7–30% of cells, depending on the cell cycle phase or hormonal background), while the expression of both markers is significantly increased during tumour transformation [13, 14]. There are several hundreds of different mAbs that detect the expression of certain proteins associated with the structural components of the cell, receptors, and products of cell synthesis (hormones, enzymes, immunoglobulins). The most widely used mAbs for IHC diagnosis of breast cancer involving molecular markers HER2, Ki-67, ER, and PgR were determined in accordance with the Nordic Immunohistochemical Quality Control (NordiQC) assessments [22]. Very low application parameters for HER2 detection use (less than 5% of the laboratories) and efficiency (pass rate 50–71%) are noted for mAb clone CB11 of Oracle
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