2014

FDA Approves First Gene-Based Test to Detect the Spread of Breast Cancer Into Lymph Nodes 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.
 
 

SOURCE Veridex, LLC

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