FDA Approves Genetic Test for Breast Cancer

Great news for those who are interested in personalized medicine. One of the first examples of this special field of medicine was the potential use of Herceptin in breast cancer. Now the U.S. Food and Drug Administration approved a genetic test for determining whether patients can be treated with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color.

Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.

Of course, patients with normal HER2 genes are not the best candidates for Herceptin therapy. So this test is not only useful for the patients but makes the whole process cost-effective as well (a full course of treatment costs about 70 000 US dollars).

That is personalized medicine…

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