A genetic test used to assess the risk of tumor recurrence and long-term survival for women with aggressive breast cancer has been approved by the FDA. TOP2AFISH 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). When used in conjunction with clinical examination and other laboratory tests, the genetic assay can refine prognosis according to Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health.

The FDA said the study validated the test for use in estimating time to local or distant recurrence as well as overall survival.
Read the FDA announcement at:
http://www.fda.gov/cdrh/mda/docs/P050045.html

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