The Food and Drug Administration today approved a breast cancer test that will help predict whether the cancer will return in five or 10 years.
The MammaPrint test evaluates 70 genes that play a role in the recurrence of a breast cancer tumor. The test predicts the chances of the tumor resurfacing at five- and 10-year periods.
It is not the first of its kind in the U.S., but it is the first to receive approval from the FDA. It is the first computer-derived test that looks at multiple genes; similar devices usually measure one or two genes, according to the FDA.
The test was developed by Agendia, a laboratory in Amsterdam, where the product has been on the market since 2005.
“This is the first test of its kind and is an important step in our journey toward having improved personalized molecular medicine as a tool for use in making better treatment decisions,” said Steve Gutman, director of the FDA’s office of In Vitro Diagnostic Device Evaluation and Safety.
Mr. Gutman warned that the test is not a perfect indicator. The test was accurate just 23 percent of the time for recurrence of breast cancer at five years for women grouped in a “high risk” category. Mr. Gutman said it is much more accurate — 95 percent — at predicting whether a woman is at low risk for a relapse.
The American Cancer Society predicts that more than 178,000 new cases of breast cancer will be diagnosed this year among U.S. women, and more than 40,000 are likely to die from the disease.