FDA approves gene test to detect spread of breast cancer into lymph nodes

Jul 17 2007

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.< br>

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."

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.