The U.S. Food and Drug Administration cleared a new genetic test on Monday that helps predict tumor recurrence and long-term survival in breast cancer patients with higher risk of the cancer returning.

The TOP2A FISH pharmDx, manufactured by Dako PMA, 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. The TOP2A FISH pharmDx test uses fluorescently labeled DNA probes to detect of confirm gene or chromosome abnormalities, a technology known as fluorescent in situ hybridization (FISH).

 “We are very pleased to announce the FDA approval of our TOP2A FISH pharmDx™ test. The TOP2A FISH pharmDx™ kit adds a new dimension to the way breast cancer will be treated in the future, giving oncologists and pathologists a reliable tool when assessing the disease prognosis for individual patients,” says Patrik Dahlén, CEO and President of Dako.

The FDA cited study data from 767 patients in Denmark that showed the test was effective in estimating the time of a tumor recurrence and overall survival.

If doctors can determine which patients have a higher risk of recurrence, they can prescribe a more effective treatment.

“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on the likely clinical course for breast cancer patients,” said FDA’s Center for Devices and Radiological Health director, Daniel Schultz, M.D.

The test is best suited for women who are premenopausal or for patients with large tumors or with tumors, which spread to the lymph nodes.

“It can also provide valuable information to assist health care providers and patients in better understanding the biology of breast cancer disease,” Schultz says.