Associated Press
Wednesday, February 7, 2007; A10

Women with early-stage breast cancer may soon get another gene test to help predict whether they are likely to have a recurrence in five to 10 years, information that could influence how aggressively the initial tumor is treated.

The MammaPrint test is not the first such predictor for breast cancer -- a competitor has been sold in the United States since 2004 -- but yesterday it became the first to win formal approval from the Food and Drug Administration.

The test is far from perfect, warned the FDA's Steven Gutman. It is much better at predicting who is not likely to relapse than who is. Gutman cited studies suggesting that when MammaPrint predicts a woman is at high risk of cancer returning in five years, it will be right just a quarter of the time. That compares with 95 percent accuracy if the test indicates she is at low risk of a relapse.

MammaPrint measures the activity of 70 genes using a tissue sample from the tumor. The agency now is debating whether existing gene-predictor tests need similar oversight, Gutman said.

MammaPrint is already sold in Europe, but it is unclear how soon sales here might begin. A spokesman for the Dutch manufacturer, Amsterdam-based Agendia, said he did not know and that a U.S. price had not been set.

"We are exploring ways to make this product available in the U.S.," a company statement said.

More than 178,000 U.S. women will be diagnosed with breast cancer this year. More than 100,000 of them will have early-stage tumors with a remarkably good prognosis: They are small, they have not yet spread to the lymph nodes, and they are sensitive to hormones.

The vast majority of those women will survive with surgery, radiation and hormone treatment. Yet guidelines today recommend chemotherapy as well for most in order to catch the few -- two or three out of every 100 patients -- who need more aggressive therapy to try to prevent a recurrence years later.