FDA approves J&J test for breast cancer spread

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WASHINGTON (Reuters) - A Johnson & Johnson test to detect if breast cancer has spread to a patient's lymph nodes won approval from U.S. health officials, the Food and Drug Administration said on Monday.

The test, called the GeneSearch Breast Lymph Node Assay, is manufactured by Johnson & Johnson unit Veridex LLC.

The molecular-based laboratory test was approved by the FDA to find cancerous growths in lymph node tissue removed from breast cancer patients. The aim is to help doctors quickly decide whether to remove more nodes during surgery, or risk having the patient undergo a second operation.

Clinical trials of more than 300 U.S. patients showed the test correctly identified 95.6 percent of people whose cancer had spread to the lymph nodes, Veridex said in a statement. That compares with about 85 percent with another procedure.

The improved accuracy means the new test could prevent second surgeries in as many as 5,200 U.S. breast cancer patients each year, Veridex said.

"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," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.

An FDA advisory panel voted 9-1 in November to urge approval for the Veridex test, but members questioned how well it would help determine the best care for patients.

The test does not show the size of the growths or how many a patient may have -- two things that can help decide future treatment, they said.
An estimated 180,000 breast cancer cases are expected to be diagnosed in the United States in 2007, according to the American Cancer Society. Nearly 41,000 Americans are projected to die from the disease this year.

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