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Disease/health condition - Cancer
Human epidermal growth factor receptor 2 immunohistochemistry 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, Treatment selection, Prognosis
Purpose
To aid in treatment and prognosis of breast cancer.
Specimen types
Formalin-Fixed, Paraffin-Embedded (FFPE) tissue blocks
WHO prequalified or recommended products
N/A
GMDN

43270

Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, 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

W01030711

IMMUNOHISTOLOGY KITS

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
Technical specifications
N/A
Related Medical Devices in MeDevIS
The SAGE IVD recommended inclusion of an immunohistochemistry test (IHC) for detecting overexpression of human epidermal growth factor receptor 2 (HER2) in patients with breast cancer to ensure appropriate treatment. The Group noted that trastuzumab, an anti-HER2 drug, is on the WHO EML. The SAGE IVD also recommended that WHO consider submissions for other endocrine diagnostics. Recommended test purpose: as an aid in the diagnosis, prognosis and treatment of breast cancer.
Human epidermal growth factor receptor 2 (HER2) testing is essential for identification of breast cancer that can be treated with trastuzumab, which is on the WHO essential medicines list (EML). Use of trastuzumab is associated with significant improvement in overall survival of HER2-positive breast cancer patients.
There is no reference standard against which to compare immunohistochemistry (IHC) for evaluation of overexpression of human epidermal growth factor receptor 2 (HER2) or the tyrosine–protein kinase erbB-2 receptor. Data from comparisons with other panels show that IHC detects about 70% of samples that are positive by any other method and do not indicate samples as positive that are not positive by any other method. There is strong evidence from trials of the benefit of HER2 testing for stratifying treatments for breast cancer according to HER2 status, which are summarized in the WHO essential medicines list (EML).
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