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Updated: May 14, 2026
Optimization of Breast Biopsy and Mastectomy Sample Collection Procedures for Biobanking, Personalized Medicine, and Research Applications
Published on: September 2, 2025
Breast cancer biomarker measurements and standards
Kenneth D Cole1, Hua-Jun He, Lili Wang
1National Institute of Standards and Technology, Gaithersburg, Maryland 20899, USA. Kenneth.cole@nist.gov
Abstract:
Cancer is a heterogeneous disease characterized by changes in the levels and activities of important cellular proteins, including oncogenes and tumor suppressors. Genetic mutations cause changes in protein activity and protein expression levels that result in the altered metabolism, proliferation, and metastasis seen in cancer cells. The identification of the critical biochemical changes in cancer has led to advances in its detection and treatment. An important example of this is the measurement of human epidermal growth factor receptor 2 (HER2), where increased expression occurs in approximately 20-30% of breast cancer tumors. HER2 is a member of the epidermal growth factor receptor family and is an important biomarker expressed on the cell surface. Measurement of the HER2 levels in tumor cells provides diagnostic, prognostic, and treatment information, because a targeted therapeutic is available. The most common methods to measure HER2 levels are immunohistochemistry and in situ hybridization assays. The accurate and reliable measurements of the specific changes in protein biomarkers for detection and treatment of cancer are important challenges. This review is focused on efforts to improve the quantitation and reliability of cancer biomarkers by using standards and reference materials.
Insights
Accurate measurement of cancer biomarkers like human epidermal growth factor receptor 2 (HER2) is crucial for diagnosis and treatment. This review explores using standards and reference materials to enhance biomarker quantitation and reliability in cancer care.
Area of Science:
- Biochemistry
- Oncology
- Molecular Biology
Background:
- Cancer is a complex disease driven by altered cellular protein activity, including oncogenes and tumor suppressors.
- Genetic mutations lead to changes in protein levels and activity, affecting cancer cell metabolism, proliferation, and metastasis.
- Identifying critical biochemical changes in cancer aids in developing detection and treatment strategies.
Purpose of the Study:
- To review efforts in improving the quantitation and reliability of cancer biomarkers.
- To highlight the importance of standards and reference materials in biomarker analysis.
- To discuss advancements in cancer detection and treatment informed by biomarker measurements.
Main Methods:
- Focus on the measurement of human epidermal growth factor receptor 2 (HER2) as a key example.
- Discussion of common HER2 measurement techniques: immunohistochemistry and in situ hybridization assays.
- Exploration of the role of standards and reference materials in quantitative assays.
Main Results:
- Increased HER2 expression is observed in 20-30% of breast cancer tumors, making it a significant biomarker.
- Accurate HER2 measurement provides vital diagnostic, prognostic, and therapeutic information.
- Challenges remain in achieving accurate and reliable quantitation of protein biomarkers.
Conclusions:
- Improving the accuracy and reliability of cancer biomarker measurements is essential for effective cancer management.
- The use of standards and reference materials is a key strategy to enhance biomarker quantitation.
- Advancements in biomarker analysis directly impact the development of targeted therapies and patient outcomes.
