Estrogen/Progesterone Receptor, Semi-Quantitative Immunohistochemistry, Manual
Use
The test is utilized for guiding decisions on hormonal therapy in patients with breast carcinomas. Estrogen receptor (ER) and progesterone receptor (PR) status are used to indicate prognosis and potential benefit from hormonal therapy. ER/PR-positive tumors are generally more likely to respond to endocrine therapy and have a better prognosis than receptor-negative tumors. Though primarily focused on breast cancer, this test may also be applied to formalin-fixed, paraffin-embedded tissue from other types of cancer, though it is done infrequently for non-breast cancer specimens.
Special Instructions
This test is for prognostic purposes only. For diagnostic purposes, order PATHC / Pathology Consultation and then request the stains. It is advised to include the pathology report and details on fixation time, fixative used, and whether the tissue was decalcified. The American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines suggest that estrogen/progesterone receptor test results are only valid for specimens fixed within specific conditions outlined. Proper adherence to collection and shipping instructions is critical.
Limitations
Testing for estrogen and progesterone receptors is not suitable for cases of lobular carcinoma in situ. The performance of immunohistochemical (IHC) stains depends significantly on proper fixation conditions. Tissue fixation delays, under- or overfixation can affect results. The test uses a modified protocol from manufacturer instructions and has not been FDA cleared or approved, though characteristics were determined following CLIA requirements.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 10480-2
- 8100-0
- 44638-5
- 21918-8
- 50595-8
- 19139-5
- 81178-6
- 62364-5
- 80398-1
Result Turnaround Time
4-6 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Submit paraffin-embedded carcinoma tissue.
Storage Instructions
Ship at ambient temperature.
Causes for Rejection
No specimen should be rejected.