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Disease/health condition - Cancer
ER/PR IHC test
Setting:
2. Laboratory
Tiered Testing Service:
Regional or provincial hospital with laboratory
Assay format
Microscopic examination
Information History
First added in 2019
Changed in 2024
Purpose type
Aid to diagnosis, Prognosis
Purpose
To aid in diagnosis, prognosis and treatment of breast cancer.
Specimen types
Formalin-Fixed, Paraffin-Embedded (FFPE) tissue blocks
WHO prequalified or recommended products
N/A
GMDN

57209

Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of estrogen (oestrogen) and/or progesterone receptors in a clinical specimen, using an enzyme immunohistochemistry method.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W0102030201; W0102030202

ESTROGEN RECEPTOR ASSAYS; PROGESTERONE RECEPTOR ASSAYS

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2017)‎. WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262 ; World Health Organization. Regional Office for the Eastern Mediterranean. (‎2006)‎. Guidelines for management of breast cancer. https://iris.who.int/handle/10665/119806 ; World Health Organization. (‎2019)‎. Guide for establishing a pathology laboratory in the context of cancer control. World Health Organization. https://iris.who.int/handle/10665/330664
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended inclusion on the EDL of the immunohistochemistry (IHC) test for expression of estrogen and progesterone receptors (ER/PR) in breast tumour tissue. The Group noted that tamoxifen and aromatase inhibitors are on the WHO essential medicines list (EML). Recommended test purpose: as an aid in the diagnosis, prognosis and treatment of breast cancer.
Expression of hormone receptors is an indicator of overall survival in both early and metastatic disease, and expression of estrogen and progesterone receptors (ER/PR) indicates treatment with hormone therapy, as recommended by the principal clinical guidelines for breast cancer management. The IHC test for hormone receptors is therefore essential for appropriate treatment of all breast cancers; the test will affect treatment decisions for more than 75% of breast cancer cases, in both early and advanced stages.
As immunohistopathology is the reference standard for assessment of estrogen and progesterone receptors (ER/PR) status in breast cancer, there are no studies of test accuracy. Trials clearly indicate the benefit to patients of testing, including the benefits of tamoxifen and aromatase inhibitors according to ER/PR status, as indicated in the WHO essential medicines list (EML). Strong evidence for differences in prognosis was also provided.
World Health Organization. (‎2019)‎. The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (‎including the second WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/329527