Breast Cancer

, Volume 21, Issue 5, pp 583–589

GeneSearch™ BLN Assay could replace frozen section and touch imprint cytology for intra-operative assessment of breast sentinel lymph nodes


    • Breast Cancer CenterShandong Cancer Hospital
  • Yan-hui Liu
    • Breast CenterGuangdong General Hospital
  • Tao Ou-yang
    • Breast CenterBeijing Cancer Hospital
  • Xin-hua Yang
    • Breast CenterSouthwest Hospital
  • Jiong Wu
    • Department of Breast SurgeryShanghai Cancer Hospital
  • Feng-xi Su
    • Department of Breast SurgeryThe Second Affiliated Hospital of Sun Yat-sen University
  • Xiao Sun
    • Breast Cancer CenterShandong Cancer Hospital
  • Wei-xia Zhong
    • Breast Cancer CenterShandong Cancer Hospital
  • Ning Liao
    • Breast CenterGuangdong General Hospital
  • Wen-tao Yang
    • Department of Breast SurgeryShanghai Cancer Hospital
Original Article

DOI: 10.1007/s12282-012-0437-z

Cite this article as:
Wang, Y., Liu, Y., Ou-yang, T. et al. Breast Cancer (2014) 21: 583. doi:10.1007/s12282-012-0437-z



Breast cancer sentinel lymph node (SLN) biopsy has become a common procedure. The GeneSearch™ Breast Lymph Node Assay is a real-time reverse-transcriptase polymerase chain reaction assay for detecting nodal metastases larger than 0.2 mm. The trial is a prospective multi-center clinical trial conducted to validate the assay in China.


Four hundred and seventy-nine consecutive prospective patients were enrolled from six centers. SLNs were sectioned along the short axis into multiple blocks. Odd blocks were tested by the assay intra-operatively, and even blocks were assessed by post-operative histology. Six 4- to 6-μm-thick sections were taken every 150 μm per block. In addition, intra-operative histological assessments were performed on the even blocks of 214 patients by frozen section (FS) and all blocks of 156 patients by touch imprint cytology (TIC).


A total of 1046 SLNs were excised. Overall performance of the assay compared to post-operative histology was accuracy of 91.4 %, sensitivity of 87.5 %, and specificity of 92.9 %. There were no significant differences in assay performance of each center. After a learning curve of about 10 cases, the assay could be performed in a median time of about 35 min. The sensitivity of the assay was similar to the FS (84.9 %, P = 0.885) and was significantly higher than the TIC (70.0 %, P = 0.007) while the specificity of all were comparable.


The GeneSearch™ Breast Lymph Node Assay is an accurate and rapid intra-operative assay for breast SLNs and it can replace FS and TIC for application.


Sentinel lymph node biopsyBreast neoplasmsIntraoperative periodPolymerase chain reactionHistological evaluation

Copyright information

© The Japanese Breast Cancer Society 2013