FDA Approves New Breast Cancer Test

WASHINGTON, D.C/ (AP) — Women with early stage breast cancer may soon get another gene test to help predict whether they will relapse in five or ten years, information that could influence how aggressively they fight the initial tumor.

The MammaPrint test is not 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.

The test is far from perfect, warned FDA’s Dr Steven Gutman.

Indeed, the MammaPrint is much better at predicting who is not likely to relapse than who is, Dr Gutman said. He cited studies suggesting that when the 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 woman is told she is at low risk of a relapse.

“This information has to be used very carefully by physicians,” Dr Gutman said. “This is a complex test. It requires use by people who know their business.”

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

“We are exploring ways to make this product available in the US,” said a company statement.

More than 178,000 US 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 would survive with surgery, radiation, and hormone treatment. Yet some — two or three out of every 100 patients — may need chemotherapy as well to try to prevent a recurrence years later.

Gene testing can help doctors and patients winnow out who is most likely to need the chemo from who can more likely skip it. For about two years, a growing number of breast cancer specialists have begun doing just that, mostly using a $3,000 gene test called Oncotype DX.

But until now, the FDA has not required formal approval of that testing, allowing sales instead as doctor-ordered services that laboratories provide, Dr Gutman said.

Tuesday’s approval does not mean the MammaPrint works better than what is already used, just that its maker sought formal FDA review and approval. The agency now is debating whether existing gene-predictor tests need similar oversight, Dr Gutman said.

How does MammaPrint work? It analyzes the level of activity of 70 genes in a sample of the woman’s surgically removed tumor, and provides a numerical ranking. Women ranked as high-risk have about twice the likelihood of a relapse in the next five to ten years as women who are ranked low-risk, Dr Gutman said.

The FDA has no information on whether the test results actually helped improve the survival of high-risk women, Dr Gutman said.