FDA approves breast cancer genetic test

The U.S. Food and Drug Administration (FDA) has approved a test that helps in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer. The TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients.

The TOP2A gene plays a role in DNA replication. Changes in the TOP2A gene in breast cancer cells mean there is an increased likelihood that the tumor will recur or that long-term survival will be decreased.

The test is suitable for breast cancer patients who are premenopausal or for whom tumor characteristics, such as tumor size or lymph node involvement, suggest a higher likelihood of tumor recurrence or decreased survival.

The FDA reviewed evidence that the test, manufactured by Dako Denmark A/S (Glostrup, Denmark), has been properly validated for its intended use.

http://www.dako.com/index/press/press-list/press-item.htm?newsid=11148&g=true

Elaine Warburton