Government okays breast cancer test

Published February 7, 2007

WASHINGTON - Women with early stage breast cancer may soon get another gene test to help predict whether they will relapse in five or 10 years, information that could influence how aggressively they fight the initial tumor.

The MammaPrint test isn't the nation's first such predictor for breast cancer - a competitor has sold here since 2004 - but on Tuesday it became the first to win formal approval from the Food and Drug Administration.

But the test is far from perfect, said the FDA's Dr. Steven Gutman.

Indeed, the MammaPrint is much better at predicting who isn't likely to relapse than who is, Gutman said.

MammaPrint already sells in Europe, but it's unclear how soon sales here would begin. A U.S. spokesman for the Dutch manufacturer, Amsterdam-based Agendia, said he didn't know.

About 178,000 U.S. women will be diagnosed with breast cancer this year. Gene testing can help doctors winnow out who's most likely to need chemotherapy, and who might gamble on skipping it.

MammaPrint analyzes the level of activity of 70 genes in a sample of the woman's surgically removed tumor, and provides a numerical ranking.