Accurate test results delivered during surgery have the potential to
prevent costly and traumatic second surgeries for breast cancer patients
WARREN, N.J., July 16 /PRNewswire-USNewswire/ -- Veridex, LLC, a
Johnson & Johnson company, has announced U.S. Food and Drug Administration
(FDA) approval of the first intra-operative and gene-based test to detect
the spread of breast cancer into the lymph nodes. The GeneSearch(TM) Breast
Lymph Node (BLN) Assay can detect the spread of cancer into the lymph nodes
more accurately than existing rapid methodologies and, as a result, has the
potential to reduce the need for stressful and costly second surgeries for
breast cancer patients.
"Given that more than 40,000 women in the U.S. die from breast cancer
annually, the demand for better medical care is extraordinarily high," said
Pat Whitworth, M.D., director of the Nashville Breast Center and a
principal investigator in the GeneSearch(TM) BLN clinical trials. "With
this new molecular pathology test, we have an opportunity to improve the
standard of care for women with this disease. Patients and physicians now
can have a higher degree of confidence in their lymph node test results
and, as a result, make more informed decisions about their treatment."
The GeneSearch(TM) BLN Assay is the first in vitro diagnostic test
approved in the United States for the rapid detection of metastases greater
than 0.2 mm in sentinel lymph node tissue removed from breast cancer
patients. In clinical trials with more than 300 patients in the U.S. that
compared performance of GeneSearch(TM) with commonly performed
intra-operative test procedures, GeneSearch(TM) correctly identified 95.6
percent of patients who had metastases in their lymph nodes. This high
accuracy in finding metastases was statistically superior to the most
commonly performed intra-operative test procedure. The new, gene-based
technology of the GeneSearch(TM) test allows for the analysis of 50 percent
of the sentinel node, versus five percent of tissue typically examined
under a microscope for evidence of cancer cells. Test results from
GeneSearch(TM) can be produced in 35 to 40 minutes during the initial
surgical procedure versus two to three days with tissue pathology.
Given its level of accuracy, GeneSearch(TM) has the potential to
prevent the need for costly and traumatic second surgeries for as many as
5,200 additional breast cancer patients in the U.S. each year.(1)
"Too often, women who have had breast cancer surgery are forced to
return for a second operation to remove lymph nodes," said Peter
Blumencranz, M.D., medical director, Breast Health Services, Morton Plant
Mease Healthcare in Clearwater, Florida. "The GeneSearch(TM) BLN test has
the potential to change that by more accurately guiding decisions during
surgery, in real-time, thereby reducing the risks, stress, emotional trauma
and costs of second surgeries."
"There is a need for a more accurate test to detect metastasized breast
cancer in a woman's lymphatic tissue -- and that's where the GeneSearch(TM)
BLN Assay comes in," said Ken Berlin, general manager, Veridex. "We now
have the opportunity to detect some metastases that could be missed by
other tests. The end result is better patient management and better patient
standard of care."
Background Information
Approximately 1.2 million women in the United States have a breast
biopsy performed each year. Of those, approximately 200,000 will be
diagnosed with breast cancer. Axillary lymph node status is one of the most
important prognostic factors for women diagnosed with the disease and
impacts the choice of post surgical therapy. Surgery to remove all axillary
lymph nodes for examination by the pathologist (axillary lymph node
dissection or ALND) remains an integral and potentially curative component
of breast cancer care. However, it is a serious procedure associated with
the risk of unwanted side effects including lymphedema, restriction of arm
movement and nerve complications. Until recently, most women underwent an
ALND unnecessarily.(2)
To better distinguish those patients who need an ALND from those who
don't, patients can now undergo a less invasive technique called sentinel
lymph node biopsy (SLNB). Sentinel node biopsy involves removing only the
first (sentinel) axillary lymph node that filters fluid from the breast, as
this node is most likely to contain cancer cells if the cancer has begun to
spread. By removing fewer lymph nodes for evaluation during an SLNB, this
procedure is less invasive than complete axillary node dissection. If there
is no evidence of cancer in the sentinel node, it is highly unlikely that
the cancer has spread to other nodes, and there may be no need for further
node removal. If the sentinel node indicates the cancer has spread,
additional axillary nodes will be removed and examined.
Veridex will initiate two post-approval studies on the GeneSearch(TM)
BLN Assay. The first study will further substantiate the turnaround time of
the test when used intra-operatively. An additional study, which will
involve more than 1,000 patients, will further validate the accuracy of
GeneSearch(TM) BLN.
The GeneSearch(TM) BLN Assay, which can be performed by trained
laboratory technicians, is also available in Europe. In the coming months
and years, Veridex will expand the GeneSearch(TM) product platform with
additional gene- based diagnostic, confirmatory, and prognostic oncology
tests for breast and other cancers.
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. http://www.veridex.com
For free broadcast-standard video related to this release, please log
onto http://www.thenewsmarket.com/jnj. Video with quotes from physicians
and a breast cancer patient are available, along with computer animation of
how the GeneSearch test works. Registration and video is free to the media.
(1)Each year, 52,000 breast cancer patients will have cancer in their
lymph nodes. Using the GeneSearch(TM) BLN Assay, with a 95 percent accuracy
rating, an estimated 49,400 patients could be identified as positive for
cancer in the lymph nodes during their first surgery. Using the other
intra- operative test, frozen section, with an estimated 85 percent
accuracy rating, approximately 44,400 patients could be identified as
positive during their first surgery. Therefore, on an annualized basis in
the U.S., application of GeneSearch(TM) BLN Assay could prevent the need
for an additional 5,200 second surgeries for breast cancer patients.
(2)Dees, EC, Shulman, LN, Souba, WW, et al. Does information from
axillary dissection change treatment in clinically node-negative patients
with breast cancer? Ann Surg 226:279-287, 1997.
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