FDA gives approval to new breast cancer test

Category Health | Permalink | 8. February 2007

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Breast cancer is cancer of breast tissue. Worldwide, it is the most common form of cancer in females, affecting approximately 10% of all women at some stage of their life in the Western world.

medlaunches.com

A new breast cancer test has been approved by FDA so that women with early stage breast cancer may soon get another gene test to help predict whether they’ll relapse in five or 10 years, information that could influence how aggressively they fight the initial tumor. There have been other breast cancers predictors in the market but MammaPrint test is the nation’s first such predictor for breast cancer to win formal approval from the Food and Drug Administration. FDA’s Dr. Steven Gutman said that “When the MammaPrint predicts a woman is at high risk of cancer returning in five years, it will be right just a quarter of the time. That compares with 95 percent accuracy if the woman is told she’s at low risk of a relapse. This information has to be used very carefully by physicians, this is a complex test. It requires use by people who know their business.”

More than 178,000 U.S. women will be diagnosed with breast cancer this year. More than 100,000 of them will have early stage tumors with a remarkably good prognosis: They’re small, they haven’t yet spread to the lymph nodes, and they’re sensitive to hormones. The FDA has no information on whether the test results actually helped improve the survival of high-risk women.

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