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Related Experiment Video

Updated: Apr 14, 2026

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
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HER2 status determination: analyzing the problems to find the solutions.

Irene Terrenato1, Ilaria Pennacchia, Simonetta Buglioni

  • 1From the Biostatistics, Scientific Direction, Regina Elena National Cancer Institute (IT); Pathology Department Catholic University of Sacred Heart (IP, VA); and Pathology Department Regina Elena National Cancer Institute-Rome, Italy (SB, MM).

Medicine
|April 18, 2015
PubMed
Summary

Accurate HER2 testing is crucial for breast cancer treatment decisions. An interlaboratory survey revealed good concordance for HER2 scores 0 and 3+, but poor agreement for scores 1+ and 2+ indicates a need for standardized testing protocols.

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Area of Science:

  • Oncology
  • Pathology
  • Clinical Diagnostics

Background:

  • Accurate human epidermal growth factor receptor 2 (HER2) testing is vital for breast cancer patient management.
  • Inconsistent HER2 testing results can negatively impact clinical decision-making and treatment efficacy.
  • Standardization of HER2 testing procedures and interpretation criteria across laboratories is essential.

Purpose of the Study:

  • To assess the concordance of HER2 scoring among different laboratories.
  • To identify common sources of discrepancy in HER2 testing.
  • To provide insights for improving the accuracy and reliability of HER2 status evaluation.

Main Methods:

  • An interlaboratory survey was conducted involving 9 hospitals in central-south Italy.
  • Each participating center submitted 36 slides, with 4 slides per HER2 score (0, 1+, 2+, 3+).
  • Slides were reviewed by revising centers to evaluate scoring concordance.

Main Results:

  • A high concordance rate was observed for HER2 scores of 0 and 3+.
  • A very low concordance rate was found for HER2 scores of 1+ and 2+.
  • Four representative cases highlighting common discrepancies in HER2 testing were analyzed.

Conclusions:

  • Current HER2 testing shows significant variability, particularly for equivocal scores (1+ and 2+).
  • Addressing technical variables and interpretation discrepancies is necessary to minimize erroneous HER2 status reporting.
  • Standardized methodologies and criteria are needed to improve the reliability of HER2 testing in breast cancer diagnostics.