WARREN, N.J., Dec. 14 /PRNewswire-USNewswire/ -- Veridex, LLC, a
Johnson & Johnson company, is pleased to announce that TIME magazine has
named the GeneSearch(TM) Breast Lymph Node (BLN) Assay one of the top ten
medical breakthroughs of 2007.
In the December 24th issue of the magazine, available today, TIME
states: "Surgeons now have a faster way to assess whether breast cancer has
spread." With GeneSearch(TM) BLN Assay, TIME goes on to say, "doctors can
accurately test the sentinel node for metastases during the initial surgery
by measuring molecular markers of breast cancer. If the test shows the
presence of cancer, the physician can remove affected lymph nodes
immediately, sparing women the wait and possible follow-up surgery."
GeneSearch(TM) BLN is the first intra-operative and gene-based test
approved for use in the U.S. to detect the spread of breast cancer into the
lymph nodes. The 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 with commonly performed intra-operative
test procedures, GeneSearch 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 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.
"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."
Given its level of accuracy, GeneSearch 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)
"In the five months since the U.S. Food and Drug Administration
approved this test, a growing number of surgeons have become familiar with
GeneSearch(TM) BLN and requested information and training so that they can
begin to offer it to their patients," said Ken Berlin, general manager,
Veridex LLC. "The accolades from Time magazine are further evidence of the
important role this test can play in the treatment of women with breast
cancer, and it reinforces our belief that GeneSearch(TM) BLN will enhance
the standard of care for the estimated 200,000 women in the U.S. who
undergo breast cancer surgery annually."
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)
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.
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 GeneSearchTM 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.
CONTACT: Steve Dnistrian: 908-218-8287
|
