SAN ANTONIO, Texas (December 16, 2006) – Results from a prospective clinical study show that the 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 study sponsored by Veridex, LLC, the GeneSearch™ BLN Assay demonstrated overall sensitivity at least 10 percentage points higher than traditional intra-operative tests. The data were presented today at the 29th Annual San Antonio Breast Cancer Symposium.
"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 treatment decisions by allowing them to determine the scope of the surgery required."
In the study involving 416 evaluable 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 compared to permanent section histology results to determine the performance of each method. The test was evaluated 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 compared 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.
The GeneSearch™ BLN Assay is CE marked to the In Vitro Diagnostic Device Directive in the European Union and became commercially available there on November 6, 2006.
Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. www.veridex.com
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