The unique monoclonal antibodies and immunochemical assay for comprehensive determination of the cell-bound and soluble HER2 in different biological samples.
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
17 Feb 2024
17 Feb 2024
Historique:
received:
11
07
2023
accepted:
14
02
2024
medline:
18
2
2024
pubmed:
18
2
2024
entrez:
17
2
2024
Statut:
epublish
Résumé
The expression of the HER2 (human epidermal growth factor receptor 2) protein in cancer cells is a well-established cancer marker used for diagnostic and therapeutic purposes in modern treatment protocols, especially in breast cancer. The gold-standard immunohistochemical diagnostic methods with the specific anti-HER2 antibodies are utilized in the clinic to measure expression level of the membrane-bound receptor. However, a soluble extracellular domain (ECD) of HER2 is released to the extracellular matrix, thus the blood assays for HER2 measurements present an attractive way for HER2 level determination. There is a need for accurate and validated assays that can be used to correlate the concentration of the circulating HER2 protein with disease clinical manifestations. Here we describe two monoclonal antibodies binding HER2 with a unique sequence of the complementarity-determining regions that recognize HER2 ECD. Development and validation of the sandwich enzyme-linked immunosorbent assay (ELISA) for quantification of the soluble HER2 in a variety of biological samples is also presented. The assay provides HER2 quantitation within a concentrations range from 1.56 to 100 ng/ml with sensitivity at the level of 0.5 ng/ml that meets the expectations for measurements of HER2 in the blood and tumor tissue samples. The method presents satisfactory intra- and inter-assay precision and accuracy for immunochemical quantification of biomarkers in biological samples. The utility of the generated monoclonal anti-HER2 antibodies has been confirmed for use in the precise measurement of HER2 (both cell-bound and soluble) in several types of biological material, including serum, solid tumor tissue, and cell culture medium. Additionally, the developed immunochemical tools have a potential for HER2 detection, not only in a wide range of sample types but also independently of the sample storage/pre-processing, allowing for comprehensive HER2 analysis in tissue (IHC), cultured cells (immunofluorescence) and blood (ELISA).
Identifiants
pubmed: 38368450
doi: 10.1038/s41598-024-54590-z
pii: 10.1038/s41598-024-54590-z
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3978Subventions
Organisme : National Centre for Research and Development
ID : STRATEGMED II/269364/5NCBR/2015
Organisme : Horizon 2020
ID : SME Instrument, grant No. 783818
Informations de copyright
© 2024. The Author(s).
Références
Iqbal, N. & Iqbal, N. Human epidermal growth factor receptor 2 (HER2) in cancers: Overexpression and therapeutic implications. Mol. Biol. Int. 2014, 1 (2014).
doi: 10.1155/2014/852748
Tsé, C., Gauchez, A. S., Jacot, W. & Lamy, P. J. HER2 shedding and serum HER2 extracellular domain: Biology and clinical utility in breast cancer. Cancer Treatment Rev. 38, 133 (2012).
doi: 10.1016/j.ctrv.2011.03.008
Reix, N. et al. A prospective study to assess the clinical utility of serum HER2 extracellular domain in breast cancer with HER2 overexpression. Breast Cancer Res. Treat. 160, 249 (2016).
doi: 10.1007/s10549-016-4000-z
pubmed: 27709352
pmcid: 5065601
Di Gioia, D. et al. Serum HER2 supports HER2-testing in tissue at the time of primary diagnosis of breast cancer. Clin. Chim. Acta 430, 86 (2014).
doi: 10.1016/j.cca.2013.12.036
pubmed: 24412321
McLemore, L. E. et al. HER2 testing in breast cancers: comparison of assays and interpretation using ASCO/CAP 2013 and 2018 guidelines. Breast Cancer Res. Treat. 187, 95 (2021).
doi: 10.1007/s10549-021-06208-5
pubmed: 33813685
Perrier, A., Gligorov, J., Lefèvre, G. & Boissan, M. The extracellular domain of Her2 in serum as a biomarker of breast cancer. Lab. Investig. 98, 696 (2018).
doi: 10.1038/s41374-018-0033-8
pubmed: 29491426
Carney, W. P. et al. Monitoring the circulating levels of the HER2/neu oncoprotein in breast cancer. Clin. Breast Cancer 5, 105 (2004).
doi: 10.3816/CBC.2004.n.014
pubmed: 15245613
Azar, F. P. & Fatemeh, H. S. Value of serum human epidermal growth factor receptor 2 (HER2)/neu testing in breast cancer patients to maximize detection of her2/neu-positive patients and susceptability to Trastuzumab. Clin. Biochem. 44, 1 (2011).
doi: 10.1016/j.clinbiochem.2011.08.483
Zuo, W. J. et al. Serum HER2 levels predict treatment efficacy and prognosis in patients with HER2-positive breast cancer undergoing neoadjuvant treatment. Gland Surg. 10, 1300 (2021).
doi: 10.21037/gs-20-802
pubmed: 33968682
pmcid: 8102211
Tse, C. et al. Increased serum maternal levels of the HER2 oncoprotein p105 ectodomain in preeclampsia. Clin. Chem. Lab. Med. 42, 142 (2004).
doi: 10.1515/CCLM.2004.026
pubmed: 15061351
Perik, P. J. et al. Serum HER2 levels are increased in patients with chronic heart failure. Eur. J. Heart Fail. 9, 173 (2007).
doi: 10.1016/j.ejheart.2006.05.010
pubmed: 16860598
Molina, R. et al. Serum levels of c-erbb-2 (her-2/neu) in patients with malignant and non-malignant diseases. Tumor Biol. 18, 188 (1997).
doi: 10.1159/000218029
Agnolon, V. et al. ELISA assay employing epitope-specific monoclonal antibodies to quantify circulating HER2 with potential application in monitoring cancer patients undergoing therapy with trastuzumab. Sci. Rep. 10, 3016 (2020).
doi: 10.1038/s41598-020-59630-y
pubmed: 32080226
pmcid: 7033231
Hnasko, R. M. & Stanker, L. H. Hybridoma technology. Methods Mol. Biol. 1318, 15 (2015).
doi: 10.1007/978-1-4939-2742-5_2
pubmed: 26160560
Andreasson, U. et al. A practical guide to immunoassay method validation. Front. Neurol. 6, 179 (2015).
doi: 10.3389/fneur.2015.00179
pubmed: 26347708
pmcid: 4541289
Bramwell, V. H. C. et al. Changes over time of extracellular domain of HER2 (ECD/HER2) serum levels have prognostic value in metastatic breast cancer. Breast Cancer Res. Treat. 114, 503 (2009).
doi: 10.1007/s10549-008-0033-2
pubmed: 18437556
Lee, M. H. et al. The significance of serum HER2 levels at diagnosis on intrinsic subtype-specific outcome of operable breast cancer patients. PLoS One 11, 1 (2016).
Shamshirian, A. et al. Diagnostic value of serum HER2 levels in breast cancer: A systematic review and meta-analysis. BMC Cancer 20, 1–10 (2020).
doi: 10.1186/s12885-020-07545-2
Wu, Y., Li, L., Zhang, D. & Ma, F. Prognostic value of the serum HER2 extracellular domain level in breast cancer: A systematic review and meta-analysis. Cancers 14, 4551 (2022).
doi: 10.3390/cancers14194551
pubmed: 36230471
pmcid: 9559205
Gall, V. A. et al. Trastuzumab increases HER2 uptake and cross-presentation by dendritic cells. Cancer Res. 77, 5374 (2017).
doi: 10.1158/0008-5472.CAN-16-2774
pubmed: 28819024
pmcid: 5626640
Krasniqi, E. et al. Immunotherapy in HER2-positive breast cancer: State of the art and future perspectives. J. Hematol. Oncol. 12, 1 (2019).
doi: 10.1186/s13045-019-0798-2
Brand, F. X. et al. Prospect for anti-HER2 receptor therapy in breast cancer. Anticancer Res. 26, 1 (2006).
Lam, L. et al. Challenges in the clinical utility of the serum test for HER2 ECD. Biochimica et Biophysica Acta – Rev. Cancer 1826, 199 (2012).
doi: 10.1016/j.bbcan.2012.03.012
Morton, A. When lab tests lie heterophile antibodies. Aust. Fam. Physician 43, 1 (2014).
Tate, J. & Ward, G. Interferences in immunoassays—Review. Clin. Biochem. Rev. 25, 1 (2004).
Preissner, C. M., Dodge, L. A., O’Kane, D. J., Singh, R. J. & Grebe, S. K. G. Prevalence of heterophilic antibody interference in eight automated tumor marker immunoassays. Clin. Chem. 51, 1 (2005).
doi: 10.1373/clinchem.2004.040501
Wolff, A. C. et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. Arch. Pathol. Lab. Med. 142, 1 (2018).
doi: 10.5858/arpa.2018-0902-SA
Tarantino, P., Curigliano, G. & Tolaney, S. M. Navigating the HER2-low paradigm in breast oncology: New standards, future horizons. Cancer Discov. 12, 2026–2030 (2022).
doi: 10.1158/2159-8290.CD-22-0703
pubmed: 35856622
Kong, H., Bai, Q., Li, A., Zhou, X. & Yang, W. Characteristics of HER2-negative breast cancers with FISH-equivocal status according to 2018 ASCO/CAP guideline. Diagn. Pathol. 17, 1 (2022).
doi: 10.1186/s13000-021-01187-z
Agersborg, S. et al. Immunohistochemistry and alternative FISH testing in breast cancer with HER2 equivocal amplification. Breast Cancer Res. Treat. 170, 321 (2018).
doi: 10.1007/s10549-018-4755-5
pubmed: 29564742
pmcid: 5999182
Vincent, O., & Nicolas, F. Human Monoclonal Antibodies: Methods and Protocols. Human Monoclonal Antibodies: Methods and Protocols vol. 1060 (2014).
Sadok, I., Rachwał, K., Jonik, I. & Staniszewska, M. Reliable chromatographic assay for measuring of indoleamine 2,3-dioxygenase 1 (IDO1) activity in human cancer cells. J. Enzyme Inhib. Med. Chem. 36, 1 (2021).
doi: 10.1080/14756366.2021.1882451
Tkaczuk-Włach, J. et al. Immunomodulatory factors in primary endometrial cell cultures isolated from cancer and noncancerous human tissue–focus on rage and ido1. Cells 10, 1 (2021).
doi: 10.3390/cells10051013
R Core Team. R Core Team 2021 R: A language and environment for statistical computing. R foundation for statistical computing. https://www.R-project.org/ . R Found. Stat. Comput. 2 (2022).