GeneSearch™ BLN Assay could replace frozen section and touch imprint cytology for intra-operative assessment of breast sentinel lymph nodes
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
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.
- GeneSearch™ BLN Assay could replace frozen section and touch imprint cytology for intra-operative assessment of breast sentinel lymph nodes
Volume 21, Issue 5 , pp 583-589
- Cover Date
- Print ISSN
- Online ISSN
- Springer Japan
- Additional Links
- Sentinel lymph node biopsy
- Breast neoplasms
- Intraoperative period
- Polymerase chain reaction
- Histological evaluation
- Industry Sectors
- Author Affiliations
- 1. Breast Cancer Center, Shandong Cancer Hospital, 440 Jiyan Rd, Jinan, People’s Republic of China
- 2. Breast Center, Guangdong General Hospital, Guangzhou, People’s Republic of China
- 3. Breast Center, Beijing Cancer Hospital, Beijing, People’s Republic of China
- 4. Breast Center, Southwest Hospital, Chongqing, People’s Republic of China
- 5. Department of Breast Surgery, Shanghai Cancer Hospital, Shanghai, People’s Republic of China
- 6. Department of Breast Surgery, The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, People’s Republic of China