Dako PMA has received marketing approval from the United States Food and Drug Administration for their assay TOP2A FISH pharmDx™. This assay is to be used as an adjunct in determining the prognosis for high-risk breast cancer.
TOP2A FISH pharmDx™ is a diagnostic test utilizing fluorescence in-situ hybridization (FISH) technique.
TOP2A is the target for anthracyclines. Results from recent studies have indicated that anthracyclines are only effective in patients with this molecular target.
TOP2A FISH pharmDX is already available for use in the European Union.
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