New HER2 Test Approved in U.S.

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The U.S. Food and Drug Administration (FDA) has approved a new way to figure out if a breast cancer is HER2-positive. The test is called SPoT-Light HER2 CISH and uses a stain that makes HER2/neu genes change color. The stain is applied to a breast cancer tissue sample and looked at with a microscope. The SPoT-Light HER2 CISH test is less complicated than the FISH (fluorescence in situ hybridization) test or the IHC (ImmunoHistoChemistry) test that are used today.

HER2-positive cancers have extra HER2 genes and make too many HER2 protein receptors. About 1 out of every 4 breast cancers is HER2-positive. HER2-positive breast cancers tend to be more aggressive than HER2-negative breast cancers.

Herceptin (chemical name: trastuzumab) and Tykerb (chemical name: lapatinib) are targeted therapies used to treat HER2-positive breast cancers. Herceptin is approved to treat women with both early-stage and advanced-stage HER2-positive breast cancer. Tykerb is approved to be given in combination with Xeloda (chemical name: capecitabine) to treat advanced, HER2-positive breast cancer that has stopped responding to anthracyclines, taxanes, and Herceptin.

Visit the Targeted Therapies section to learn more about HER2-positive breast cancer, Herceptin, and Tykerb.

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