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The United States Food and Drug Administration (FDA) recently approved the GeneSearch™ BLN Assay to detect whether breast cancer cells have spread to lymph nodes under the arm. GeneSearch BLN Assay is the first molecular-based lab test to detect this stage of cancer.

One of the first places that breast cancer will spread to is the lymph nodes under the arm (axillary nodes). The prognosis of a patient with early breast cancer is greatly affected by whether the cancer has spread to axillary nodes; therefore, accurate testing for spread to axillary nodes is a critical step in determining the best course of treatment.

Standard testing for the spread of cancer to axillary lymph nodes involves examining part of one or more lymph nodes in the laboratory. Often just the sentinel lymph node (the first lymph node to collect lymph drainage from the breast) is removed and evaluated for the presence of cancer cells. If cancer exists in the sentinel node, more axillary lymph nodes are removed for examination. Test results may take a couple of days, so patients whose cancer has spread to several lymph nodes are often required to undergo a second surgery to remove more nodes.

The GeneSearch BLN Assay is a test that can detect molecules that are abundant in normal breast tissue but typically not present in a normal lymph node. The GeneSearch BLN Assay can test for these molecules from lymph node(s) removed during surgery. The clinical trial that prompted the FDA to approve GeneSearch BLN Assay included 416 patients who underwent testing with the GeneSearch BLN Assay as well as with standard lymph node testing.

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  • The GeneSearch BLN Assay accurately detected 88% of women who had cancer spread to axillary lymph nodes.
  • The GeneSearch BLN Assay accurately identified 94% of women who did not have cancer spread to axillary lymph nodes.

Patients with newly diagnosed breast cancer may wish to speak with their physician regarding their individual risks, benefits, and access to the GeneSearch BLN Assay.

Reference: United States Food and Drug Administration. FDA Approves First Molecular-Based Lab Test to Detect Metastatic Breast Cancer. Available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01667.html. Accessed July 2007.

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