Sentinel node staging for breast cancer: intraoperative molecular pathology overcomes conventional histologic sampling errors

Detection of breast cancer metastasis in sentinel lymph nodes using intra-operative real time GeneSearch™ BLN Assay in the operating room: results of the Cardiff study

“…The GeneSearch assay was compared with exhaustive serial frozen sectioning practiced by the European Institute of Oncology in Milan and was found to have an equivalent sensitivity to serial frozen sections taken every 1.5-2 mm [4]. A large, multicenter, prospective evaluation by several U.S. centers and a smaller feasibility study by Jules Bordet Institute, Belgium showed sensitivity of over 87% similar to that found in our study, suggesting the technique is reproducible across centers [3,10].…”

“…Our study was a feasibility study and therefore underpowered to address sensitivity of the assay, although the results are generally consistent with the other larger trials [3]. The GeneSearch assay was compared with exhaustive serial frozen sectioning practiced by the European Institute of Oncology in Milan and was found to have an equivalent sensitivity to serial frozen sections taken every 1.5-2 mm [4].…”

“…MG and CK 19 are expressed at high levels in tissue of breast origin but not at all or only at low levels in normal lymph node tissue. The quantitative expression results are then applied against cutoffs for these genes that have been demonstrated to correlate with detection of metastasis with the current ''gold standard'' method of formalin-fixed, paraffin embedded (permanent section) H&E histology [3]. The assay is intended to detect metastasis to the same level as it is detected by permanent section H&E histology, but is intended to be used as an intra-operative test during SLN biopsy, thus providing the surgeon with immediate SLN status allowing the option of full ALND to be done at the time of the same operation.…”

“…The assay has been validated in previous studies [3,4]. This study evaluates the feasibility of intra-operative assessment of SLN using the GeneSearch TM Breast Lymph Node (BLN) Assay (Veridex, LLC, Warren, NJ) within the UK NHS healthcare system.…”

Evaluation of the histological size of the sentinel lymph node metastases using RT–PCR assay: a rapid tool to estimate the risk of non-sentinel lymph node invasion in patients with breast cancer

“…Real-time RT-PCR assays were performed in a one-step reaction in which the expression of three markers genes -mammaglobin (MG), CK-19 and an internal control (IC; porphobilinogen deaminase, PBGD) -was evaluated. Cycle threshold (Ct) cut-off values were predetermined and validated for each marker by the manufacturer on the basis of 2 prospective multisite U.S. clinical trials [9,10]. Cut-off Ct values were ≤31 for MG and ≤30 for CK-19.…”