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Genetic test for breast cancer approved by FDA

The US Food and Drug Administration has approved a genetic test to determine if patients with breast cancer are good candidates for treatment with Herceptin
The US Food and Drug Administration (FDA) has approved a genetic test to determine if patients with breast cancer are good candidates for treatment with Herceptin.

The SPOT-Light HER 2 CISH kit, developed and produced by Invitrogen in the US, is designed to measure the number of copies of the HER2 gene, which regulates the growth of cancer cells, in tumour tissue.

A healthy breast cell has two copies of the HER2 gene, which sends signals to cells telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of the HER2 gene, prompting them to over-produce HER2 protein, resulting in cells growing and dividing too quickly.

The SPOT-Light test counts the number of HER2 genes in a small sample remove from the tumour patients who over-produce HER2 are treated with Herceptin which helps prevent the growth of HER2 cancer cells.

Dr Daniel Schultz, director of the FDA's centre for devices and radiological health, said: "When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer."

8th July 2008

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