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FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
Date:6/14/2011

samples from 510 patients with breast cancer. This study showed that the test was effective in confirming that a patient's tumor sample contained more than the normal number of copies of the HER2 gene in 96 percent of the HER2 positive tumor samples. Patients with more than the normal number of copies of the HER2 gene are considered candidates for Herceptin therapy.

The study also showed that the test was effective at excluding the possibility that more than the normal number of copies of the HER2 gene were present in 92.3 percent of the HER2 negative tumor samples. Patients who do not have more than the normal number of copies of the HER2 gene are typically not candidates for Herceptin therapy. The ability to identify patients who are HER2-positive is a useful tool for physicians who may be considering treatment with Herceptin for their breast cancer patients.

Breast cancer is the second leading cause of cancer-related death among women. An estimated 207,090 new cases of breast cancer were diagnosed in the United States during 2010 and about 39,840 women died from the disease, according to the National Cancer Institute. About 20 percent of women diagnosed with breast cancer are HER2-positive.

Tucson, Ariz.-based Ventana Medical Systems manufactures the Inform Dual ISH test. Herceptin is marketed by South San Francisco based-Genentech, a member of the Roche Group.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Device Approvals and Clearances

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

NCI: Breast Cancer

http://www.cancer.gov/cancertopics/types/breast

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SOURCE U.S. Food and Drug Administration
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