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Optimization of a Multiplex RNA-based Expression Assay Using Breast Cancer Archival Material
Published on: August 1, 2018
Improved breast cancer biomarker detection through a simple, high frequency, low cost external proficiency testing
Tawny Hung1, Robert Wolber, John Garratt
1Department of Pathology, Vancouver General Hospital and University of British Columbia, Vancouver, Canada. tawnyhung@gmail.com
Pathology
|November 18, 2010
Summary
A low-cost, high-frequency external proficiency testing program improved breast cancer biomarker detection, specifically for HER2 and progesterone receptor (PR), without mandating lab changes. This sustainable program enhances diagnostic accuracy across institutions.
Area of Science:
- Oncology
- Pathology
- Laboratory Medicine
Background:
- Accurate detection of breast cancer biomarkers like oestrogen receptor (ER), progesterone receptor (PR), and HER2 is crucial for effective treatment.
- External proficiency testing (EPT) programs are vital for maintaining laboratory quality and diagnostic accuracy.
Purpose of the Study:
- To describe a simple, low-cost, high-frequency immunohistochemistry (IHC) EPT program.
- To demonstrate the program's impact on improving breast cancer biomarker detection rates in clinical laboratories.
Main Methods:
- A 30-month EPT program was conducted in British Columbia, Canada, involving twelve clinical laboratories.
- Tissue microarray slides were used across nine testing runs to assess laboratory performance for ER, PR, and HER2 detection.
- Sensitivity for each biomarker was calculated for every laboratory and testing run.
Main Results:
- Mean sensitivities were 97.1% for ER, 84.8% for PR, and 90.7% for HER2.
- Significant improvement in HER2 sensitivity was observed over time (87.0% to 92.9%, p=0.04).
- A positive trend towards improved PR sensitivity was noted (81.9% to 88.1%, p=0.13), while ER sensitivity remained consistently high.
Conclusions:
- The described IHC EPT program is simple, low-cost, and highly sustainable.
- The program effectively enhances breast cancer biomarker detection accuracy.
- It is readily implementable in various multi-institutional settings or regional networks.

