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U.S. Department of Health and Human Services

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Test Detects the Spread of Breast Cancer

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The first molecular-based laboratory test for detecting whether breast cancer has spread (metastasized) to nearby lymph nodes was approved by FDA on July 16, 2007. The GeneSearch BLN Assay, manufactured by Veridex, a Johnson & Johnson Company, of Warren , N.J., detects molecules that are abundant in breast tissue but scarce in a normal lymph node.

The Importance of Lymph Nodes

Lymph nodes are part of the system that helps protect the body against infection. The first lymph node that filters fluid from the breast is called the “sentinel node,” because that is where breast cancer cells are likely to spread first.

The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide the appropriate treatment for a woman with metastatic breast cancer.

“The GeneSearch BLN Assay offers a new approach to sentinel node testing,” says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. “Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation.”

During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination under a microscope. Sometimes the sentinel node is examined immediately, and if tumor cells are found, additional lymph nodes are removed.

A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the woman may require a second surgery to remove the remaining lymph nodes.

Test Effectiveness

In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 women. The test accurately predicted nearly 88% of the time that breast cancer had spread in women with metastasis. Women without metastasis were identified accurately 94% of the time.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: July 17, 2007