Lab Test to Detect Metastatic Breast Cancer


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FDA News
FOR IMMEDIATE RELEASE
July 16, 2007

Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves First Molecular-Based Lab Test to Detect Metastatic
Breast Cancer

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01667.html


The U.S. Food and Drug Administration today approved the first
molecular-based laboratory test for detecting whether breast cancer
has spread (metastasized) to nearby lymph nodes. The GeneSearch BLN
Assay detects molecules that are abundant in breast tissue but scarce
in a normal lymph node.

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 appropriate therapy for a woman with metastatic
breast cancer.

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.

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 patient may require a second surgery to
remove the remaining lymph nodes.

"The GeneSearch BLN Assay offers a new approach to sentinel node
testing," said Daniel Schultz, M.D., director of the FDAs 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."

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

Most of the women were also studied to compare the BLN Assay with
immediate microscopic examination during surgery. The test gave fewer
false negative results, but slightly more false positive results. A
false negative test result, when the cancer has actually spread, may
delay the needed removal of additional lymph nodes. A false positive
test, indicating metastasis when there is none, may result in a more
extensive surgery and puts the women at risk of unnecessary
lymphedema (swelling due to fluid build-up following lymph node
removal) and other side effects.

The GeneSearch BLN Assay is manufactured by Veridex, a Johnson &
Johnson Company, of Warren, N.J.

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