FDA approves genetic test for women with breast cancer

BMJ 1998; 316 doi: (Published 17 January 1998) Cite this as: BMJ 1998;316:167
  1. Deborah Josefson
  1. San Francisco

    The Food and Drug Administration in the United States 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 cancers.

    The test will be manufactured by Oncor under the name Inform and is expected to be commercially available for a cost of about $200 (£125) within three months. This is the first time a gene based test for cancer has been approved by the Food and Drug Administration. The predictive value of the test, however, is controversial.

    About 180 000 women in the United States are diagnosed with breast cancer annually, and 44 000 die of the …

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