MammaPrint has been sold in the Netherlands since 2005. It was developed by Dutch scientists from Agendia, a laboratory that used new microarray analysis, which studies the patterns of behavior of large numbers of genes, to study the genetic profiles of women with breast cancer.
Researchers compared the genetic profiles of a large number of breast cancer patients and found 70 genes whose activity would most likely determine if tumors return. They then analyzed breast tumor tissue samples and calculated the risks of the cancer spreading.
As part of the FDA approval process, Agendia submitted data on tumor samples from 302 patients at five European centers. The studies showed that the test was useful in predicting the length of time until future metastasis in women who were under age 61 and in the two earliest stages of breast cancer. In the study group, the breast cancers were 5 centimeters or less in size and none of the women showed evidence that their cancer had spread to nearby lymph nodes.
According to the FDA, the microarray results may help oncologists and physicians plan follow-up treatment or monitoring for women considered at higher risk of recurring cancer. But officials said the tests should be used in conjunction with other clinical information and laboratory tests.
The FDA will hold a public hearing February 8 to discuss new guidelines for regulating the use of the new microarray analysis tests.
Copyright 2007 iVillage Total Health.
