TOP2A FISH pharmDx: New Genetic Test for Breast Cancer, FDA-Approved

Approved by the FDA, a genetic test that can help in the assessment of risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer – TOP2A FISH pharmDx – is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients.

The TOP2A gene plays a role in DNA replication. The TOP2A FISH pharmDx test uses fluorescently labeled DNA probes to detect or confirm gene or chromosome abnormalities, a technology known as fluorescent in situ hybridization (FISH).

The recurrence of cancer depends partly on certain genes whose activity may be altered by changes in the number of gene copies in the tumor. Changes in the TOP2A gene in breast cancer cells mean there is an increased likelihood that the tumor will recur or that long-term survival will be decreased.

Manufactured by Dako Denmark A/S (Glostrup, Denmark), TOP2A FISH pharmDx is suitable for the following breast cancer patients:

1. premenopausal
2. tumor characteristics (such as tumor size or lymph node involvement) suggest a higher likelihood of tumor recurrence or decreased survival

Find more details from the FDA News.