ROCKVILLE, Maryland—Dako’s TOP2A FISH pharmDx assay has received FDA approval for use as an adjunct to existing clinical and pathological information in determining the prognosis for patients with relatively high-risk breast cancer.
It is the first approved test for assessing clinical breast cancer tissue specimens for amplifications and deletions of the topoisomerase 2-alpha gene.
This information aids physicians in evaluating the prognosis for breast cancer patients, since patients with normal topo 2-alpha status have a better outcome than patients with topo 2-alpha gene amplifications or deletions.
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.
Topo 2-alpha appears to be a molecular target for the pharmacologic action of anthracyclines, with implications for use of these agents, the Danish-based company said. In a new analysis of the BCIRG 006 trial data, anthracyclines were beneficial only in the subset of patients who had co-amplification of HER2 and the topo 2-alpha gene (see Oncology News International January 2008, page 1).