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Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells

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Current technologies for HER2 testing in breast cancer.

C B Moelans¹, R A de Weger, E Van der Wall

¹Department of Pathology, University Medical Center Utrecht, The Netherlands. cmoelans@umcutrecht.nl

Critical Reviews in Oncology/Hematology

|January 29, 2011

Summary

Current HER2 testing methods for breast cancer show discrepancies, with no single gold standard. Clinical decisions on testing strategies will likely depend on practical and economic factors, emphasizing standardization and quality control.

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Area of Science:

Oncology
Molecular Diagnostics
Biomarker Analysis

Background:

Molecular techniques are crucial for breast cancer detection, prognosis, and treatment response prediction.
HER2/neu status is a key predictor of sensitivity to targeted therapies like trastuzumab and lapatinib.
Various methods exist for HER2 assessment, including protein, RNA, and DNA-based assays.

Purpose of the Study:

To provide an overview of recent advancements in HER2 testing methodologies.
To discuss the current landscape and challenges in HER2 status assessment for breast cancer.

Main Methods:

Review of existing and emerging molecular techniques for HER2 testing.
Analysis of comparative studies evaluating different HER2 assessment strategies.
Discussion on protein-, RNA-, and DNA-based assays, including in situ hybridization (ISH) systems.

Main Results:

Despite good correlation in studies, discrepancies persist among various HER2 testing techniques.
No single method is universally accepted as the gold standard due to inherent advantages and disadvantages.
Lack of consensus exists regarding the superiority of protein vs. gene-based tests, ISH probe systems, and automation levels.

Conclusions:

The selection of a HER2 testing strategy is influenced by practical and economic considerations pending large clinical trials.
Standardization, robust quality control, laboratory accreditation, and automation are vital for reliable HER2 testing.
Future directions emphasize automated tissue processing and image analysis for improved HER2 interpretation.