Hormone Receptor Studies (Estrogen and Progesterone) by Immunohistochemistry (IHC)

ER/PR, ER, ERPR, Estrogen Receptor, Progesterone Receptor , SOFT: MERPG

Specimen Collection Criteria

Collect (preferred specimen): Formalin-fixed, paraffin-embedded block with corresponding H&E slide. Tissue shold be well fixed and well processed.

  • Please provide a pathology report with each specimen, including the type of fixative and hours duration of fixation (if known).
  • Per ASCO-CAP guidelines, tissue with minimum dimensions of 1.0 cm x 1.0 cm x 0.4 cm must be fixed for a minimum of 6 hours and a maximum of 48 hours in 10% neutral buffered formalin.
  • Tissue that cannot be immediately processed for paraffin-embedding should be transferred to 70% ethanol for storage after fixation for 18 hours in formalin. Indicate fixation time of the test requisition form.

Also acceptable: One H&E slide plus 3 unstained tissue sections cut at 4.0 um thick and placed on charged slides. Air dry, do not oven dry. Tissue adherence cannot be guaranteed for sections placed on plain glass slides. Send all slides within 6 weeks of cutting.

Specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, source of specimen, and fixation time, if known. Please provide a pathology report with each specimen.

Physician Office/Drawsite Specimen Preparation

Maintain paraffin-embedded tissue or slides at room temperature (20-25°C or 68-77°F) until transport.

Preparation for Courier Transport

Transport: Paraffin-embedded tissue, at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

  • Tissue in fixatives other than 10% formalin or zinc formalin.
  • Improper labeling, inadequate information.


Twice weekly.
Results available in 7 business days.

Reference Range

Negative: 0-0.9% reactive cells.
Positive: Greater than 1% reactive cells.

Test Methodology

Immunoperoxidase staining and detection of hormone receptors (ER and PR) is performed on formalin-fixed, paraffin-embedded tissue sections using polymer-based detection system. 4-micron tissue sections are deparaffinized, subjected to heat-induced antigen retrieval and then sequentially incubated with anti-receptor monoclonal antibodies (ER clone 1D5; Pr clone PgR 636) and following by a polymer detection reagent. Sections are subsequently treated with the chromogen diaminobenzidine and the substrate hydrogen peroxide to produce a brown nuclear precipitate in cells expressing receptors. Sections are lightly counterstained with hematoxylin.


Immunoperoxidase-stained slides are quantitated using digital imaging. The pathologist will provide an interpretive report. Reactivity is reported as negative (0 - 0.9% reactive cells) or postive (greater than 1% reactive cells). This is in accordance with the ASCO-CAP guidelines for testing estrogen and progesterone receptors in breast cancer.

Clinical Utility

The test is most frequently used in breast carcinomas when decisions on hormonal therapy must be made.

NOTE: Estrogen/progesterone receptor testing is not appropriate and not performed for cases of lobular carcinoma in-situ.


  1. Battifora, H, et al. Estrogen Receptor Immunohistochemical Assay in Paraffin-Embedded Tissue: A Better Gold Standard - Applied Immunohistochemistry, 1(1):39-45, 1993.
  2. Ogawa, Y, Moriya, T, Kato, Y, et al. Immunohistochemical Assessment for Estrogen Receptor and Progesterone Receptor Status in Breast Cancer: Analysis for a Cut-Off Point as the Predictor for Endocrine Therapy. Breast Cancer 11(3):267-275, 2004.
  3. Hammond, Elizabeth, et al. American Society of Clinical Oncology/College of American Pathologist Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer. Arch Pathol Lab Med. 2010 Jul;134(7):e48-72.

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