ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients

Frontiers in Oncology

Oncology

Lei Jiang¹  Ying Yin¹  Guohua Yu¹  Yunjun Wang¹  Jiandi Zhang²  Yan Lyu²  Fangrong Tang²  Maozhou Yang² 

[1] Laboratory of Molecular Pathology, Department of Pathology, Affiliated Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, China;Yantai Quanticision Diagnostics, Inc., a Division of Quanticision Diagnostics, Inc. (US), Yantai, Shandong, China;

关键词: HER2;    QDB;    FFPE;    LOD;    HER2-low;    ELISA;    IHC;    T-DXd;   

DOI  :  10.3389/fonc.2023.920698

 received in 2022-04-14, accepted in 2023-02-21,  发布年份 2023

来源: Frontiers

【 摘 要 】

Inherent issues of subjectivity and inconsistency have long plagued immunohistochemistry (IHC)-based Her2 assessment, leading to the repeated issuance of guidelines by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) for its standardization for breast cancer patients. Yet, all these efforts may prove insufficient with the advent of Trastuzumab deruxtecan (T-Dxd), a drug with the promise to expand to tumors traditionally defined as Her2 negative (Her2−). In this study, we attempted to address these issues by exploring an ELISA-like quantitative dot blot (QDB) method as an alternative to IHC. The QDB method has been used to measure multiple protein biomarkers including ER, PR, Ki67, and cyclin D1 in breast cancer specimens. Using an independent cohort (cohort 2) of breast cancer formalin-fixed paraffin-embedded (FFPE) specimens, we validated cutoffs developed in cohort 1 (Yu et al., Scientific Reports 2020 10:10502) with overall 100% specificity (95% CI: 100–100) and 97.56% sensitivity (95% CI: 92.68–100) in cohort 2 against standard practice with the dichotomized absolutely quantitated values. Using the limit of detection (LOD) of the QDB method as the putative cutoff point, tumors with no Her2 expression were identified with the number comparable to those of IHC 0. Our results support further evaluation of the QDB method as an alternative to IHC to meet the emerging need of identifying tumors with low Her2 expression (Her2-low) in daily clinical practice.

【 授权许可】

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Copyright © 2023 Yu, Lyu, Jiang, Wang, Yin, Zhang, Yang and Tang