TUESDAY, Feb. 6, 2007 (HealthDay News) -- The U.S. Food and Drug Administration has approved a test designed to predict the chances of breast cancer returning or spreading within five to 10 years after a woman's initial cancer.
The MammaPrint test studies "the patterns of behavior" of some 70 genes that may play a part in tumor recurrence, offering doctors a better chance of predicting the chances of a tumor returning or spreading, the FDA said in a statement.
The gene activity is measured from a sample of a woman's surgically removed tumor. The test was developed by Agendia, a laboratory based in the Netherlands, where the product has been on the market since 2005, the FDA said.
MammaPrint is the first in a class of complex molecular tests known as an in vitro diagnostic multivariate index assay. As part of the approval process, Agendia submitted clinical data from 302 patients at five European study centers showing that the test was useful in predicting cancer recurrence among women under age 61 who had early-stage breast tumors that were five centimeters or smaller, the agency said.
The American Cancer Society predicts 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.
To learn more about the MammaPrint test, see the U.S. Food and Drug Administration's approval announcement.