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Comparison Study Finds FISH Assay More Accurate Than HercepTest.(fluorescence in situ hybridization more accurate in the determination of Herceptin use for breast cancer therapy)
2001 JUN 14 -- (NewsRx Network) -- The most common laboratory test to determine the eligibility for Herceptin use produces many false-positive results, potentially causing thousands of women with breast cancer to receive Herceptin therapy unnecessarily, researchers report.
In an analysis of tumor samples from 400 women newly diagnosed with breast cancer - the most complete study to date - researchers found that the U.S. Food and Drug Administration-approved HercepTest produced false-positive results in 12% of patients studied compared to FISH (Fluorescence in situ Hybridization) and mRNA laboratory analysis.
False-positive readings would likely result in use of Herceptin, which can be toxic when combined with chemotherapy.
"By extrapolating the study results to the approximately 180,000 new cases of breast cancer diagnosed in the year 2000, these findings suggest that thousands of women may potentially be misclassified as having Her-2/neu positive breast cancer," says lead author Raymond Tubbs, MD, chairman of the Department of Clinical Pathology at the Cleveland Clinic Foundation, Ohio.
"If a HercepTest produces a positive result, especially a 2+ result, ...
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Source: HighBeam Research, Comparison Study Finds FISH Assay More Accurate Than...