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TIME Magazine Names Genesearch™ One of The Top 10 Medical Breakthroughs in 2007


Veridex, LLC, a Johnson & Johnson company, is pleased to announce that TIME magazine has named the GeneSearch™ Breast Lymph Node (BLN) Assay one of the top 10 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™ 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.”

The GeneSearch™ BLN Assay 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™ BLN Assay 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™ 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™ 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™ 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 the GeneSearch™ BLN Assay 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 the GeneSearch™ BLN Assay 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 monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays.

For free broadcast-standard video related to this release, please log onto 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 GeneSearchTM 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.


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