Consensus Recommendations on Estrogen Receptor Testing in Breast Cancer By Immunohistochemistry

Authors:
  • CTClive R. Taylor
    Clive R. Taylor
  • NGNeal S. Goldstein
    Neal S. Goldstein
  • DDDavid J. Dabbs
    David J. Dabbs
  • EHElizabeth H. Hammond
    Elizabeth H. Hammond
  • BHBryan Hewlett
    Bryan Hewlett
  • AFAlton D. Floyd
    Alton D. Floyd
  • TBTodd S. Barry
    Todd S. Barry
  • AMAlvn W. Martin
    Alvn W. Martin
  • FBFrederick Baehner
    Frederick Baehner
  • RCRichard W. Cartun
    Richard W. Cartun
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Abstract
Estrogen receptor (ER) status in breast cancer is currently the most important predictive biomarker that determines breast cancer prognosis after treatment with endocrine therapy. Although immunohistochemistry has been widely viewed as the gold standard methodology for ER testing in breast cancer, lack of standardized procedures, and lack of regulatory adherence to testing guidelines has resulted in high rates of “false-negative” results worldwide. Standardized testing is only possible after all aspects of ER testing—preanalytical, analytical, and postanalytical, have been closely controlled. A meeting of the “ad-hoc committee” of expert pathologists, technologists, and scientists, representing academic centers, reference laboratories, and various agencies, issued standardization testing recommendations, aimed at optimization of clinical ER testing environment, as a step toward improved standardized testing.

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