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FDA APPROVES GENETIC TESTS FOR BREAST CANCER

The FDA has recently approved a gene-based test that may help to predict the recurrence of breast cancer. The test detects levels of Her2/neu, a gene on chromosome 17, which is amplified in a subset of breast cancer. The test will be manufactured by Oncar under the name Inform and is expected to be commercially available at a cost of about $200. This is the first time a gene-based test for cancer has been approved. About 180,000 women in the U.S. are diagnosed with breast cancer annually and 44,000 die of the disease each year. About a third of breast cancers test positive for amplification of the Her2/neu gene.


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