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New Test Identifies Aggressive Breast Cancer

New Test Identifies Aggressive Breast Cancer

The FDA recently approved a new genetic test, called Inform Dual ISH, that helps determine whether women with breast cancer have the human epidermal growth factor receptor 2 (HER2)-positive type.1 In about 20% of breast cancers, the cancer cells produce an excess of the protein HER2 because of a gene mutation. HER2-positive breast cancers tend to be more aggressive and respond less well to hormone therapy. Therefore, women with HER2-positive breast cancer are candidates for treatment with trastuzumab (Herceptin), which specifically targets HER2 and is often used with chemotherapy.

Using a standard microscope for amplification, laboratory personnel can use the Inform Dual ISH test to count the number of copies of the HER2 gene on chromosome 17 in tumor tissue on the same slide. Patients whose tumors have more than the normal number of copies of the HER2 gene are candidates for treatment with trastuzumab. This information is essential when developing a treatment plan.

“The faster a treatment plan is formulated, the easier it is for a woman to deal with her diagnosis,” says Stephanie Bernik, MD, chief of surgical oncology at Lenox Hill Hospital in New York. “When faced with too many unknowns, the diagnosis of breast cancer can be overwhelming. Because this test can be performed in a standard lab, the information regarding HER2 status will be known quickly, and a woman will know if her treatment will be over within a few months or might go on for a full year.”2


1. U.S. Food and Drug Administration. FDA approves new test to help determine if breast cancer patients are candidates for Herceptin treatment.  Accessed June 16, 2011.
2. The National Women’s Health Information Center. FDA approves test that spots aggressive breast cancer. Accessed June 16, 2011.

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