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Topo 2 alpha test FDA approved

Topo 2 alpha test FDA approved

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).

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