Study Results Show GeneSearch(TM) Breast Lymph Node Assay Rapidly Detects Breast Cancer Metastases With Greater Sensitivity Than Traditional Tests

Test provides surgeon with real-time information that may aid treatment


Dec 18, 2006, 00:00 ET from Veridex, LLC

    SAN ANTONIO, Dec. 18 /PRNewswire/ -- Results from a prospective
 clinical study show that the GeneSearch(TM) 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(TM) 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(TM)
 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(TM) 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(TM) 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
 GeneSearch(TM) 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 GeneSearch(TM) 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 GeneSearch(TM) BLN Assay was 18 percentage points
 greater than the overall sensitivity of TP. In the same patient comparison,
 overall specificity of the GeneSearch(TM) 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(TM) 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(TM) 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.
     About Veridex
     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(TM) assays
 that identify, enumerate and characterize circulating tumor cells directly
 from whole blood; and GeneSearch(TM) assays that use molecular technology
 to diagnose, stage and more accurately characterize tumors.