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Jul 17, 2007

First Gene-Based Test for Breast Cancer Metastasis Okayed

  • Veridex reported that the first intra-operative and gene-based test to detect the spread of breast cancer into the lymph nodes has been approved. The GeneSearch™ Breast Lymph Node (BLN) Assay can detect the metastasized  cancer more accurately than existing methodologies, according to the company.

    "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 BLN Assay comes in," comments 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."

    The GeneSearch BLN Assay is the first in vitro diagnostic test approved in the U.S. for the rapid detection of metastases greater than 0.2 mm in sentinel lymph node tissue removed from breast cancer patients, Veridex continues. The test allows for the analysis of 50% of the sentinel node, versus 5% of tissue typically examined under a microscope for evidence of cancer cells. Results can be obtained 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," notes study investigator Peter Blumencranz, M.D., medical director, Breast Health Services, Morton Plant Mease Healthcare in Clearwater, FL. "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."

    Veridex plans to conduct two post-approval studies on the GeneSearch BLN Assay to substantiate the turnaround time of the test when used intra-operatively and to validate the accuracy. The company also intends to expand the GeneSearch product platform with additional gene-based diagnostic, confirmatory, and prognostic oncology tests for breast and other cancers.



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