TUESDAY, Jan. 15 (HealthDay News) -- TOP2A FISH pharmDx -- a first-of-its-kind genetic test for breast cancer patients -- received approval Jan. 14 from the U.S. Food and Drug Administration to help assess the risk of cancer recurrence and mortality in high-risk patients, primarily those who are premenopausal.
Manufactured by Dako Denmark A/S (Glostrup, Denmark), the TOP2A FISH pharmDx test uses fluorescent in situ hybridization to identify changes in the TOP2A (topoisomerase 2 alpha) gene in cancer patients. According to the FDA release, suitable candidates for the test are premenopausal breast cancer patients or those with certain tumor characteristics linked to increased risk of recurrence or decreased survival.
The FDA's action was prompted by a study of 767 Danish patients with high-risk tumors. The study showed that the test helped predict the time to recurrence and overall survival in women who received certain chemotherapy regimens.
"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," Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health, said in a statement. "It can also provide valuable information to assist health care providers and patients in better understanding the biology of breast cancer disease."
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