FDA approves new test which detects breast cancer spread

Jul 16 2007

The Food and Drug Administration (FDA) in the U.S. has given approval for a new test to be used which can detect if breast cancer has spread to a patient's lymph nodes.

The test is called the GeneSearch Breast Lymph Node Assay and is manufactured by drug manufacturer Johnson & Johnson.

The test detects molecules that are abundant in breast tissue but are normally rare in lymph nodes; the first lymph node that filters fluid from the breast is called the "sentinel node", which is commonly removed during a lumpectomy or mastectomy as it is where breast cancer cells are most likely to spread first.

The lymphatic system protects the body from infection and the GeneSearch test offers an additional way to evaluate the sentinel node.

It is the first molecular-based laboratory test which will find cancerous growths in lymph node tissue removed from breast cancer patients and it aims is to help doctors quickly decide whether to remove more nodes during surgery, or run the risk of the patient having to undergo a second operation.

Following clinical trials of more than 300 U.S. patients the test correctly identified 95.6 percent of people whose cancer had spread to the lymph nodes, which is a better result than the 85 percent achieved by means of another procedure.

The improved accuracy should in effect ensure that as many as 5,200 U.S. breast cancer patients each year will avoid a second bout of surgery.

Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health says the rapid results achieved with the test means patients can be assessed while still on the operating table, thus preventing the need for more surgery later.

An FDA advisory panel voted in November for approval for the test, but noted that the test does not show the size of the growths or how many a patient may have, two factors which might help decide future treatment.

According to the American Cancer Society an estimated 180,000 breast cancer cases are expected to be diagnosed in the United States in 2007, and almost 41,000 Americans are expected to die from the disease.

The test is manufactured by a Johnson & Johnson subsidiary company, Veridex, LLC.