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FDA Approves Dako's Genetic Test for Breast Cancer Recurrence

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved a genetic test made by Dako Denmark designed to predict if a breast cancer tumor will recur and a patient’s chances of long-term survival, the FDA said yesterday.
The TOP2A FISH pharmDx test uses fluorescent in situ hybridization to detect or to confirm abnormalities in the topoisomerase 2 alpha gene, which is involved in DNA replication. Changes in this gene in breast cancer cells can be used to predict likelihood of tumor recurrence or long-term survival of a patient. The FDA said the TOP2A FISH pharmDx is the first test to be approved that targets the TOP2A gene in cancer patients.
The FDA has deemed the test suitable for premenopausal patients or those who have other indicators of higher chances of tumor recurrence, such as tumor size or lymph node involvement, or decreased survival.
The test was studied in Danish patients who were treated with chemotherapy after removal of breast cancer tumors. That study used data from tumor samples and clinical data from 767 patients with high-risk tumors, and it confirmed that the test was useful in estimating recurrence and survival in women who had received chemotherapy, said the FDA.
Dako received the CE mark for the test last summer and has since launched the assay in Europe. A Dako spokesperson said that the firm expects to launch the test in the US in April or May.

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