FDA Approves Gene Test to Aid Breast Cancer Prognosis

ROCKVILLE, Md., Jan. 16 -- The FDA has approved a genetic test that can be used to assess risk of tumor recurrence and long-term survival for women with aggressive breast cancers.
The TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients.
The test uses fluorescent in situ hybridization (FISH) to detect abnormalities in TOP2A, a gene that plays a role in DNA replication. The FDA said that changes in TOP2A in breast cells correlate with risk of recurrence.
Used in conjunction with clinical examination and other laboratory tests, the genetic assay can refine prognosis, said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.
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 said.
The approval was based on data from a study of tumor samples and clinical evaluation of 767 Danish women with breast cancers known to have a high risk of recurrence. The test analyzed tissue from resected tumors.
The FDA said the study validated the test for use in estimating time to local or distant recurrence as well as overall survival.
Although this is the first test to analyze TOP2A in women with breast cancer, it is not the first FDA-approved genetic test for breast cancer.
In 2006, the FDA approved MammaPrint, a microarray genetic analysis used for predicting risk of stage I or II breast cancer recurrence or metastasis. The TOP2A FISH pharmDx is manufactured by Dako Denmark A/S of Glostrup, Denmark.