Abstract

The research and application for treatment determination and monitoring of biomarkers in hormone replacement therapy is a comparably novel domain. Currently, regulations are limited and insufficient, but are evolving. Nevertheless, there is decisive anticipation of what future biomarker research will reveal and apply more specifically to negative symptoms and adverse disorders, particularly affecting females—with the end goal of improving and enhancing their quality of life.

Considering multiple biological outcomes, hormone replacement therapy (HRT) performs a vital role in determining treatment recommendations and regimes for many menopausal symptoms and conditions: cancer, diabetes, cognitive decline, osteoporosis, and autoimmune disorders.

Targeted treatments are challenging to achieve for some female hormone-related conditions and disorders. Nevertheless, physicians frequently order biomarker analyses. Conventional biomarkers, such as blood glucose, blood pressure, hormone levels, and mineral levels, can be identified in in-clinic labs. However, reference laboratories are typically utilized to develop biomarker panels, especially for rare or novel biomarker analysis, thus ensuring appropriate therapeutic regimes.

Biomarkers, measured in the body, influence or predict the incidence of outcome or disease. Biomarkers are more characterized explicitly as biomarkers of risk stratification, disease detection, diagnosis, prognosis, and predictive of a disease or disorder.

Biochemical markers comprise lipids, inflammatory (high-sensitivity C-reactive protein, interleukin-6, tumor necrosis factor-alpha, and leukocyte count), adipokines, endothelial (E-selectin, P-selectin, ICAM, and VCAM), glucose tolerance (fasting glucose, insulin, HOMA-IR, IGF-1, and metabolic syndrome), hemostatic (D-dimer, factor VIII, von Willebrand factor, homocysteine, fibrinogen, tissue factor pathway inhibitor, and acquired activated protein C resistance), matrix metalloproteinases, and sex steroid hormones (such as globulin-binding sex hormone).

Genetic markers cover factor V Leiden, glycoprotein IIIa leu33pro, gene variants (related to sex hormone biosynthesis, metabolism, and signaling), genome-wide association studies (GWAS), and exome sequencing (for gene discovery), gene variants (in the ABO blood group), and polymorphisms (of estrogen and progesterone receptors).

Various and distinct technologies are utilized to measure specific body fluids, cellular content, tissue-based composition, and other physiological measures; also, imaging techniques are employed. Biomarkers may be hormones, enzymes, glycoproteins, oncofetal antigens, receptors, or changes in tumors (such as mutations, amplifications, or translocations). Specific biomarkers are identified in special studies for the same or similar diseases or disorders.

Keywords: Blood Panels; Biopsy; Hormones; Risk Stratification; Specimen; Validity

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