Guidelines on clinical practice of molecular tests in breast cancer in China (2025 edition).

Breast cancer is one of the most prevalent malignancies among women globally and ranks second in the incidence of malignant tumors among Chinese women. It has become a significant public health issue that seriously threatens women's health, highlighting the urgent need to establish a precision prevention and treatment system. Currently, the diagnosis and treatment of breast cancer have transitioned from traditional histological classification to a precision medicine phase centered on molecular characteristics, significantly enhancing the specificity and effectiveness of clinical treatments. With the rapid development of molecular biology techniques, the continuous discovery and application of new biomarkers have fueled the growing demand for molecular pathological testing in clinical settings. The widespread use of various molecular testing platforms has driven clinical decision-making from population-based and standardized approaches to individualized and refined strategies. This shift enables clinicians to more accurately assess patient prognosis and predict treatment responses, thereby formulating more appropriate treatment plans. However, the emergence of new technologies and biomarkers has also increased the requirements for standardization, normalization of testing procedures, and the establishment of quality control. While this trend brings new opportunities for precision diagnosis and treatment of breast cancer, it also poses higher demands on clinical and pathological practices, necessitating the establishment of unified precision diagnosis and treatment pathways and consensus. The "Guidelines on clinical practice of molecular tests in breast cancer in China (2025 edition)" was developed through a multidisciplinary collaboration among experts in molecular pathology and breast oncology, integrating domestic clinical realities with international advancements. We systematically evaluated evidence quality (GRADE criteria) and recommendation strength based on global clinical studies and practical experiences. The guideline aims to harmonize localized molecular diagnostic expertise with global insights, addressing critical needs in precision therapeutics, hereditary susceptibility assessment, and prognostic recurrence risk stratification. It proposes optimized clinical testing algorithms, emphasizes multidisciplinary integration, and establishes standardized protocols to ensure robust implementation of molecular diagnostics in China. This document serves as an authoritative reference for clinicians and pathologists to refine individualized patient management and jointly promotes the realization of the "Healthy China 2030" strategic goal.