Resources for Food and Drug Administration (FDA)
FDA Approves Gene Test to Aid Breast Cancer Prognosis
www.medpagetoday.co 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.
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