Consensus recommendations on estrogen receptor testing in breast cancer by immunohistochemistry

Appl Immunohistochem Mol Morphol. 2008 Dec;16(6):513-20. doi: 10.1097/PAI.0b013e31818a9d3a.


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.

Publication types

  • Consensus Development Conference
  • Practice Guideline

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Biomarkers, Tumor / metabolism*
  • Breast Neoplasms / diagnosis*
  • Breast Neoplasms / drug therapy
  • Breast Neoplasms / metabolism
  • Breast Neoplasms / pathology
  • Chemotherapy, Adjuvant
  • Diagnostic Errors / prevention & control
  • Enzyme-Linked Immunosorbent Assay / standards
  • Female
  • Humans
  • Immunohistochemistry / methods*
  • Immunohistochemistry / standards*
  • Receptors, Estrogen / metabolism*
  • Sensitivity and Specificity
  • Specimen Handling / standards
  • Tamoxifen / administration & dosage
  • Tissue Fixation / standards


  • Biomarkers, Tumor
  • Receptors, Estrogen
  • Tamoxifen