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Disease/health condition - Cancer
Panel of immunohistochemical (IHC) markers for diagnosis of of hematologic malignancies
Assay format
Microscopic examination
Information History
First added in 2019
Changed in 2024
Purpose type
Aid to diagnosis, Prognosis
Purpose
To aid in the diagnosis, subclassification, prognosis and treatment of hematologic malignancies.
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
The SAGE IVD recommended inclusion of the basic panel of IHC tests for diagnosis of lymphoma, noting that identification of lymphoma subtypes can indicate the appropriate treatment. They also noted the requirement for qualified pathologists. Recommended test purpose: as an aid in the diagnosis, sub-classification, prognosis and treatment of lymphoma (including HIV-associated conditions).
The widely different types of lymphoma require different treatment approaches, and the sub-groups can often be differentiated only by IHC. Diagnosis of lymphoma and other haematological malignancies by immunophenotyping and IHC is established in high-income countries and is essential for individualized care for response and long-term survival. This panel of markers aids in appropriate diagnosis and sub-classification of lymphomas and allows faster triaging of patients for adapted treatment. Once a diagnosis is suspected, a trained laboratory technologist can use an appropriate algorithm to produce additional stains to aid the pathologist who is assessing the case. This will shorten the turn-around time for diagnosis, which will improve the timeliness of treatment decisions. The test is cost–effective.
Evidence was provided that the proposed panel of markers is adequate to subtype the majority of lymphomas efficiently. As immunohistopathology is considered the reference standard, no estimate of accuracy was reported. The benefits of using this panel of markers for subtyping is presumed to be based on evidence of the benefits of different treatment approaches for different lymphoma types.
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