New Test Helps Evaluate Breast Cancer Patients for
TUESDAY, June 14 (HealthDay News) -- A genetic test to help
doctors evaluate whether women with breast cancer are candidates
for treatment with the drug Herceptin (trastuzumab) has been
approved by the U.S. Food and Drug Administration.
The Inform Dual ISH test measures whether there are excessive
copies of the HER2 gene in breast tumor tissue. HER2-positive
breast cancer is a fast-growing, aggressive form of the disease,
making up about 20 percent of all breast cancer cases, the FDA said
in a news release. Women with an above-normal number of copies of
the HER2 gene are candidates for Herceptin therapy.
Clinical studies involving 510 women with breast cancer showed
the new test was 96 percent accurate in identifying HER2-positive
tumor samples, the agency said. The test correctly identified
HER2-negative tumors in 92.3 percent of cases.
Breast cancer is the second-leading cause of cancer deaths among
women, the FDA said, citing some 207,090 cases diagnosed in the
United States last year, and about 39,840 deaths from the
The new test is produced by Ventana Medical Systems, based in
National Institutes of Health has more about
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