WASHINGTON, Jan. 15 (UPI) -- The U.S. Food and Drug Administration has approved a test that helps assess the risk of tumor recurrence in high-risk breast cancer patients.
The FDA said the TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients.
Since it's known that changes in the TOP2A gene in breast cancer cells mean there's an increased likelihood the tumor will recur or that long-term survival will be decreased, the new test uses fluorescently labeled DNA probes to detect or confirm gene or chromosome abnormalities
"When used with other clinical information and laboratory tests, this test can provide healthcare professionals with additional insight on the likely clinical course for breast cancer patients," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
The FDA said the new 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 test is manufactured by Dako Denmark A/S of Glostrup, Denmark.
