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Disease/health condition - Cancer
Panel of immunohistochemical (IHC) markers for diagnosis of solid tumours
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 solid tumours, especially childhood cancer.
Specimen types
Formalin-Fixed, Paraffin-Embedded (FFPE) tissue blocks
WHO prequalified or recommended products
N/A
EMDN

W01030709

PRIMARY ANTISERA FOR IMMUNOHISTOLOGY

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
Haematolymphoid Tumours WHO Classification of Tumours, 5th Edition, Volume 11, 2024. https://publications.iarc.who.int/Book-And-Report-Series/Who-Classification-Of-Tumours/Haematolymphoid-Tumours-2024 ; 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. (‎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
The SAGE IVD recommended inclusion on the EDL of the basic panel of IHC tests for the diagnosis of solid tumours (to be used only in tertiary level). The group noted that the panel is to be extended in future submissions. Recommended test purpose: to aid in diagnosis, prognosis and treatment of solid tumours especially in childhood cancer. In 2020 WHO proposed adding a series of markers to the panel, specifically: SALL4, PLAP, Oct3/4, NANOG, CD30 and CD117/c-kit, and WT1 to the IHC panel for diagnosis of solid tumours. The working group accepted the evidence provided (available at: https://iris.who.int/handle/10665/339064) and agreed to add the proposed markers to the panel.
The basic panel of IHC stains is applicable in the clinical and pathological diagnosis of solid malignancies in a resource-sparing algorithm for settings with limited diagnostic tools or molecular testing. The panel is clinically useful for classification of solid tumours for prognosis and treatment of paediatric and adult solid malignancies. The panel should be considered a starting-point for the diagnosis of solid tumours, to which other antigens will be added, as appropriate. In 2020 WHO proposed adding a series of markers to the panel, specifically: SALL4, PLAP, Oct3/4, NANOG, CD30 and CD117/c-kit, and WT1 to the IHC panel for diagnosis of solid tumours. The working group accepted the evidence provided (available at: https://iris.who.int/handle/10665/339064) and agreed to add the proposed markers to the panel.
IHC is the reference standard for classification thus no studies of the accuracy of the approach are available. Evidence provided supported stepwise testing using a restricted batch of antibodies as an efficient testing process. In 2020 WHO proposed adding a series of markers to the panel, specifically: SALL4, PLAP, Oct3/4, NANOG, CD30 and CD117/c-kit, and WT1 to the IHC panel for diagnosis of solid tumours. The working group accepted the evidence provided (available at: https://iris.who.int/handle/10665/339064) and agreed to add the proposed markers to the panel.
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 ; World Health Organization. (‎2021)‎. The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (‎including the third WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/339064