Integrating Practice with Precision: A Quantitative HER2 Protein Assay Developed for Clinical Application in Trastuzumab Deruxtecan Treatment Guidance - Takeaways - MDSpire

Integrating Practice with Precision: A Quantitative HER2 Protein Assay Developed for Clinical Application in Trastuzumab Deruxtecan Treatment Guidance

  • By

  • Junmei Hao

  • Xiaochun Fei

  • Fangfang Zou

  • Qian Hu

  • Linlin Du

  • Liya Yu

  • Xuanye Bai

  • Shasha Bi

  • Qinghua Cao

  • Weishan Chen

  • Qun Dai

  • Tingting Guo

  • Hai Huang

  • Wenwei Jiang

  • Baohua Li

  • Lixia Li

  • Jingjing Liu

  • Tong Liu

  • Xiaoqin Liu

  • Jiahong Lyu

  • Yue Pan

  • Xiaoqing Shao

  • Fangrong Tang

  • Tingting Wang

  • Cuiping Zhang

  • Yongcun Zhu

  • Job Tien Chiang Liu

  • Nicole Salazar

  • Shukun Zhang

  • Jiandi Zhang

  • Xiaosong Chen

  • Chaofu Wang

  • April 27, 2026

  • 0 min

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  • 1

    A quantitative HER2 assay using the Quantitative Dot Blot (QDB) method was developed to improve accuracy in assessing HER2 levels for T-DXd treatment.

  • 2

    The QDB assay demonstrated higher consistency than immunohistochemistry (IHC), with an inter-rater ICC of 0.877 compared to 0.513 for IHC.

  • 3

    ROC analysis of the QDB assay achieved an AUC of 0.9477, indicating strong diagnostic performance in distinguishing HER2 levels.

  • 4

    The QDB assay identified a cutoff of 0.2746 nmole/g, achieving overall concordance rates of up to 92% in validation cohorts.

  • 5

    The study supports the QDB HER2 assay as a reliable alternative to guide T-DXd usage, particularly for distinguishing HER2-low from HER2-0.

Original Source(s)

Integrating Practice with Precision: A Quantitative HER2 Protein Assay Developed for Clinical Application in Trastuzumab Deruxtecan Treatment Guidance

  • by Junmei Hao, Xiaochun Fei, Fangfang Zou, Qian Hu, Linlin Du, Liya Yu, Xuanye Bai, Shasha Bi, Qinghua Cao, Weishan Chen, Qun Dai, Tingting Guo, Hai Huang, Wenwei Jiang, Baohua Li, Lixia Li, Jingjing Liu, Tong Liu, Xiaoqin Liu, Jiahong Lyu, Yue Pan, Xiaoqing Shao, Fangrong Tang, Tingting Wang, Cuiping Zhang, Yongcun Zhu, Job Tien Chiang Liu, Nicole Salazar, Shukun Zhang, Jiandi Zhang, Xiaosong Chen, Chaofu Wang

  • April 27, 2026

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