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The US Food and Drug Administration (FDA) has approved a new genetic test for determining whether breast cancer patients are good candidates for treatment with the drug herceptin (trastuzumab).
A healthy breast cell has two copies of the HER2 gene, which regulates the growth of cancer cells by sending a signal which tells them when to grow, divide and make repairs. Breast cancer patients can have more than two copies of the gene, meaning HER2 protein is overproduced and more signals are sent to breast cells which then grow and divide too quickly.
The SPOT-Light HER2 CISH kit is a novel test which measures the number of copies of the HER2 gene in tumour tissue. When used alongside other clinical information and laboratory tests, it could provide healthcare professionals with additional insight on treatment decisions.
Patients who over-produce HER2 protein are typically treated with herceptin, which targets HER2 protein production and helps to stop the growth of HER2 cancer cells.
The FDA based its approval of the SPOT-Light test on a study using tumour samples from patients with breast cancer in the US and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.
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US Food and Drug Administration
