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Related Experiment Video

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Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
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Benchmarking a large regional UK HER2 testing service against current practice guidelines.

Jeremy Thomas1, Joseph Loane1, Richard Matthews1

  • 1Pathology Service, NHS Lothian, Edinburgh, UK.

Journal of Clinical Pathology
|October 7, 2016
PubMed
Summary

Single HER2 FISH counting with rapid screening is safe and practical under strict parameters. This approach, alongside centralized testing, allows for detailed auditing of the HER2 testing process.

Keywords:
AUDITBREAST CANCERFISHIMMUNOCYTOCHEMISTRYLABORATORY SAFETY

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Pathology

Background:

  • Accurate HER2 (Human Epidermal growth factor Receptor 2) testing is crucial for breast cancer treatment decisions.
  • Current UK guidelines necessitate robust and reliable HER2 testing methodologies.

Purpose of the Study:

  • To evaluate HER2 testing data from 3500 cases over 28 months.
  • To assess the safety and efficacy of single versus double counting in HER2 FISH testing.
  • To review findings in the context of UK reporting guidelines.

Main Methods:

  • Analysis of HER2 immunohistochemistry (IHC) and fluorescent in situ hybridisation (FISH) data.
  • Review of reagents, analytical machines, and scoring profiles.
  • Examination of double counting and rapid screening protocols for FISH analysis.
  • Utilisation of custom spreadsheet scripts for data recording and analysis.

Main Results:

  • No significant differences in scoring profiles based on testing machine or reagent batch for HER2 IHC and FISH.
  • Excellent concordance observed between biomedical scientists and pathologists.
  • Significant differences in score proximity for double-scored cases with HER2 copy number >6.0 versus <6.00.
  • Identified safe parameters for single HER2 FISH scoring with rapid screening (HER2/CEP17 ratio <1.5 and HER2 copy number <3.5).

Conclusions:

  • Single HER2 FISH counting with a secondary rapid screen is a safe and feasible method within defined parameters.
  • HER2 copy number influences score proximity in double-scored cases, with higher spreads at elevated copy numbers.
  • Centralization of HER2 testing in regional centers facilitates comprehensive auditing of the analytical workflow.