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 hi
Contact: Steve Dnistrian