Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis

The HER2 gene is a biomarker for breast cancer prognosis and treatment. Overexpression of HER2 protein determined by immunohistochemistry (IHC) or amplification of the HER2 gene determined by fluorescence in situ hybridization (FISH) is a condition for qualifying patients for anti-HER2 therapy. Du...

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Main Authors: Andrzej Marszałek, Agata Kubicka, Inga Jagiełło, Anna Malicka-Durczak
Format: Article
Language:English
Published: Termedia Publishing House 2023-07-01
Series:Polish Journal of Pathology
Subjects:
Online Access:https://www.termedia.pl/Potential-impact-of-HercepTest-mAb-PharmDx-Dako-Omnis-ge001-in-breast-cancer-diagnosis,55,51058,1,1.html
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author Andrzej Marszałek
Agata Kubicka
Inga Jagiełło
Anna Malicka-Durczak
author_facet Andrzej Marszałek
Agata Kubicka
Inga Jagiełło
Anna Malicka-Durczak
author_sort Andrzej Marszałek
collection DOAJ
description The HER2 gene is a biomarker for breast cancer prognosis and treatment. Overexpression of HER2 protein determined by immunohistochemistry (IHC) or amplification of the HER2 gene determined by fluorescence in situ hybridization (FISH) is a condition for qualifying patients for anti-HER2 therapy. Due to the high toxicity of anti-HER2 treatment, proper patient selection is essential. In our study we compared 40 cases with IHC staining of HER2 antibody determined by Ventana PATHWAY anti-HER2/neu antibody (4B5) as HER2 2+ with the new antibody (HercepTest™ mAb PharmDx [Dako Omnis] [GE001]). Then using a double-blind study we compared the (IHC) evaluation with FISH results. In 65% of cases (26/40) the IHC 2+ score remained unchanged, in 32.5% of cases (13/40) expression of HER2 protein after IHC with new antibody was indicated as 3+ score, and in one case we observed a decrease of HER2 protein expression to 1+. In all cases but one, in which we found IHC HER 3+ with new antibody, there was FISH amplification. We have reason to believe that the new antibody will reduce the diagnostic time and avoid unnecessary costs. Due to the small study group, further investigation is needed.
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spelling doaj.art-d6bcc86cdfe04e089a56060083398c632023-09-05T11:56:09ZengTermedia Publishing HousePolish Journal of Pathology1233-96872084-98692023-07-01742828810.5114/pjp.2023.12935251058Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosisAndrzej MarszałekAgata KubickaInga JagiełłoAnna Malicka-DurczakThe HER2 gene is a biomarker for breast cancer prognosis and treatment. Overexpression of HER2 protein determined by immunohistochemistry (IHC) or amplification of the HER2 gene determined by fluorescence in situ hybridization (FISH) is a condition for qualifying patients for anti-HER2 therapy. Due to the high toxicity of anti-HER2 treatment, proper patient selection is essential. In our study we compared 40 cases with IHC staining of HER2 antibody determined by Ventana PATHWAY anti-HER2/neu antibody (4B5) as HER2 2+ with the new antibody (HercepTest™ mAb PharmDx [Dako Omnis] [GE001]). Then using a double-blind study we compared the (IHC) evaluation with FISH results. In 65% of cases (26/40) the IHC 2+ score remained unchanged, in 32.5% of cases (13/40) expression of HER2 protein after IHC with new antibody was indicated as 3+ score, and in one case we observed a decrease of HER2 protein expression to 1+. In all cases but one, in which we found IHC HER 3+ with new antibody, there was FISH amplification. We have reason to believe that the new antibody will reduce the diagnostic time and avoid unnecessary costs. Due to the small study group, further investigation is needed.https://www.termedia.pl/Potential-impact-of-HercepTest-mAb-PharmDx-Dako-Omnis-ge001-in-breast-cancer-diagnosis,55,51058,1,1.htmlbreast cancer her2 ihc fish
spellingShingle Andrzej Marszałek
Agata Kubicka
Inga Jagiełło
Anna Malicka-Durczak
Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis
Polish Journal of Pathology
breast cancer
her2
ihc
fish
title Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis
title_full Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis
title_fullStr Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis
title_full_unstemmed Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis
title_short Potential impact of HercepTest™ mAb PharmDx (Dako Omnis) (ge001) in breast cancer diagnosis
title_sort potential impact of herceptest™ mab pharmdx dako omnis ge001 in breast cancer diagnosis
topic breast cancer
her2
ihc
fish
url https://www.termedia.pl/Potential-impact-of-HercepTest-mAb-PharmDx-Dako-Omnis-ge001-in-breast-cancer-diagnosis,55,51058,1,1.html
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