FDA Approves Herceptin Pharmacogenetic Test for Breast Cancer Treatment

The use of genetic information to inform pharmaceutical treatments is known as pharmacogenetics/pharcogenomics.  The FDA has argued for its authority to approve such tests, despite the fact that it does not approve most commercially offered genetic tests in the U.S.  Now the FDA has approved another genetic test, the Dual ISH test manufactured by Ventana Systems, which will determine which women could benefit from the use of the monoclonal antibody treatment, Herceptin, which will be particularly helpful to patients whose cancer cells exhibit the HER-2 protein.  The FDA notes: "HER-2 overexpression and gene amplification should be determined using FDA-approved tests with an indication for the specific tumor type being tested." Other HER-2 tests are available, including one offered by Genentech, which produces Herceptin.