1262P - Use of droplet digital PCR for quantitative and automatic analysis of the HER2 status in breast cancer patients

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancers in Adolescents and Young Adults (AYA)
Breast Cancer
Translational Research
Basic Principles in the Management and Treatment (of cancer)
Presenter Kazutaka Otsuji
Citation Annals of Oncology (2017) 28 (suppl_5): v449-v452. 10.1093/annonc/mdx378
Authors K. Otsuji1, T. Sasaki2, A. Tanaka2, A. Kunita2, M. Ikemura2, K. Matsusaka3, K. Tada1, M. Fukayama2, Y. Seto4
  • 1Department Of Breast And Endocrine Surgery, Faculty Of Medicine, The University of Tokyo, 113-8655 - Tokyo/JP
  • 2Department Of Pathology, Faculty Of Medicine, The University of Tokyo, 113-8655 - Tokyo/JP
  • 3Department Of Molecular Oncology, Graduate School Of Medicine, Chiba University, 260-8670 - Chiba/JP
  • 4Department Of Stomach And Esophageal Surgery, Faculty Of Medicine, The University of Tokyo, 113-8655 - Tokyo/JP



Digital polymerase chain reaction (dPCR) has been used to yield an absolute measure of nucleic acid concentrations. Recently, a new method referred to as droplet digital PCR (ddPCR) has gained attention as a more precise and less subjective assay to quantify DNA amplification. We demonstrated the usefulness of ddPCR to determine HER2 gene amplification of breast cancer.


In this study, we used ddPCR to measure the HER2 gene copy number in clinical formalin-fixed paraffin-embedded samples of 41 primary breast cancer patients. To improve the accuracy of ddPCR analysis, we also estimated the tumour content ratio (TCR), the ratio of tumour cell count per section, for each sample.


Our determination method for HER2 gene amplification using the ddPCR ratio (ERBB2:ch17cent copy number ratio) combined with the TCR showed high consistency with the conventionally defined HER2 gene status according to ASCO-CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines (P 


The introduction of ddPCR to determine the HER2 gene status in breast cancer is feasible for use in clinical practice and might complement or even replace conventional methods of examination in the future.

Clinical trial identification

Legal entity responsible for the study

The University of Tokyo




All authors have declared no conflicts of interest.