Scientific Impact Recognition Award. Sentinel node staging for breast cancer: intraoperative molecular pathology overcomes conventional histologic sampling errors

Am J Surg. 2007 Oct;194(4):426-32. doi: 10.1016/j.amjsurg.2007.07.008.


Background: When sentinel node dissection reveals breast cancer metastasis, completion axillary lymph node dissection is ideally performed during the same operation. Intraoperative histologic techniques have low and variable sensitivity. A new intraoperative molecular assay (GeneSearch BLN Assay; Veridex, LLC, Warren, NJ) was evaluated to determine its efficiency in identifying significant sentinel lymph node metastases (>.2 mm).

Methods: Positive or negative BLN Assay results generated from fresh 2-mm node slabs were compared with results from conventional histologic evaluation of adjacent fixed tissue slabs.

Results: In a prospective study of 416 patients at 11 clinical sites, the assay detected 98% of metastases >2 mm and 88% of metastasis greater >.2 mm, results superior to frozen section. Micrometastases were less frequently detected (57%) and assay positive results in nodes found negative by histology were rare (4%).

Conclusions: The BLN Assay is properly calibrated for use as a stand alone intraoperative molecular test.

Publication types

  • Validation Study

MeSH terms

  • Adenocarcinoma / pathology*
  • Adenocarcinoma / surgery
  • Adult
  • Breast Neoplasms / pathology*
  • Breast Neoplasms / surgery
  • Diagnostic Errors*
  • Humans
  • Intraoperative Care
  • Neoplasm Staging
  • Prospective Studies
  • Sentinel Lymph Node Biopsy*
  • Specimen Handling / standards*