GeneSearch- Breast Lymph Node (BLN) Assay, a gene-based diagnostic test has greater sensitivity than traditional intra-operative methods of detecting the spread of breast cancer to the lymph nodes. In the recent study that was presented at 29th Annual San Antonio Breast Cancer Symposium GeneSearch- Breast Lymph Node (BLN) Assay was shown to do give superior results. GeneSearch- BLN Assay demonstrated overall sensitivity at least 10 percentage points higher than traditional intra-operative tests.

"These results indicate the potential advantage of the GeneSearch- BLN Assay as an objective, standardized test that can assess breast cancer metastasis in the lymph nodes rapidly and with greater overall sensitivity than the current standard of care," said study investigator Peter W. Blumencranz, MD, FACS, Medical Director of Comprehensive Breast Health and Cancer Services, Morton Plant Mease Healthcare, and Medical Director of Moffitt Morton Plant Cancer Care, Clearwater, Florida. "This intra-operative test may provide surgeons with critical information that can help them optimize therapy decisions by allowing them to determine the scope of the surgery required".

In the study that was presented involves 416 patients across 11 clinical trial sites, sentinel lymph nodes were tested using the GeneSearch- BLN Assay and current methods for assessing nodal tissue during surgery (frozen section (FS) or touch preparations (TP)). All nodes were sampled for permanent section hematoxylin/eosin (H&E), and most were also sampled for immunohistochemistry (IHC). The GeneSearch- BLN Assay, FS and TP results were each in comparison to permanent section histology results to determine the performance of each method. The test was reviewed in terms of sensitivity and specificity, which measure how well the method correctly identifies nodes with and without clinically relevant metastases. Tests with lower sensitivity have a higher chance of false negatives, and tests with lower specificity have a higher chance of false positives.

In a head-to-head comparison with FS, overall sensitivity of the GeneSearchTM BLN Assay was 95.6 percent-10 percentage points greater than the overall sensitivity of FS (85.6 percent). In the same patient comparison, overall specificity of the GeneSearchTM BLN Assay remained high with a value of 94.3 percent in comparison to the 97.8 percent overall specificity of FS. In a head-to-head comparison with TP, overall sensitivity of the GeneSearchTM BLN Assay was 18 percentage points greater than the overall sensitivity of TP. In the same patient comparison, overall specificity of the GeneSearchTM BLN Assay remained at 100 percent for both the assay and TP.

"This innovative test has the potential to improve intra-operative pathology and surgical decision making, reduce the need for second surgeries, and thereby significantly improve patient care," said Mark Myslinski, General Manager, Veridex.

Sentinel lymph node biopsy (SLNB) is a widely used and accepted procedure in the management of breast cancer. SLNB involves removing the first (sentinel) lymph node that filters fluid from the breast, as this node is the most likely to contain cancer cells if the cancer has begun to spread. If there is no evidence of metastases in the sentinel node, it is unlikely that the cancer has spread to other nodes, and there may be no need for further surgery. Results of the GeneSearch- BLN Assay can typically be reported during the operation within 30 to 40 minutes from the time the sentinel node is removed. The test outcomes are intended to be used to guide the decision to excise additional lymph nodes and to aid in patient staging.


Posted by: Jesmi24    Source

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