title: GeneSearch™ BLN Assay could replace frozen section and touch imprint cytology for intra-operative assessment of breast sentinel lymph nodes.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Breast Cancer Center, Shandong Cancer Hospital, 440 Jiyan Rd, Jinan, People's Republic of China, wangysh2008@yahoo.com.cn.
authors: Yong-sheng
authors: YS
authors: Wang
authors: Yan-hui
authors: YH
authors: Liu
authors: Ou-yang
authors: OY
authors: Tao
authors: Xin-hua
authors: XH
authors: Yang
authors: Jiong
authors: J
authors: Wu
authors: Feng-xi
authors: FX
authors: Su
authors: Xiao
authors: X
authors: Sun
authors: Wei-xia
authors: WX
authors: Zhong
authors: Ning
authors: N
authors: Liao
authors: Wen-tao
authors: WT
authors: Yang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000235:genetics / Q000473:pathology* / Q000601:surgery*; D005260:Female; D005629:Frozen Sections / Q000379:methods; D006801:Humans; D007432:Intraoperative Period; D008207:Lymphatic Metastasis / Q000235:genetics* / Q000473:pathology; D008875:Middle Aged; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013997:Time Factors; D055815:Young Adult