SAN ANTONIO, Dec. 16 /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
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.
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.
SOURCE Veridex, LLC