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Human Epidermal Growth Factor Receptor 2
Medical studies have demonstrated that 14 to 16 percent of patients are incorrectly labeled with overexpression of the gene, and another 18 to 22 percent of patients are incorrectly reported with gene underexpression. Oncology professional guidelines recommend giving the drug only if the HER2 gene is overexpressed because medical studies show that it is ineffective in patients with an underexpressed or absent gene. Potentially severe cardiac side effects from Herceptin also demand careful selection of patients.
The recent news release from the oncology and pathology groups suggests that many breast cancer patients may have had inaccurate testing for the HER2 gene. This important test helps oncologists determine if a breast cancer patient will respond to the potentially life-saving drug trastuzumab (Herceptin, Genentech). The College of American Pathologists announced a new certification program for HER2 testing that will be effective in 2008.
UnitedHealthcare Members Covered for HER2 Gene Retesting
UnitedHealthcare members with breast cancer have coverage for retesting if they are concerned that their test may be inaccurate. The College of American Pathology certification won't be completed until 2008. In the interim period, UnitedHealthcare suggests using high-volume laboratories with published results. Two laboratories, LabCorp and Genzyme Genetics, have served as reference laboratories for second opinions and published those results in peer-reviewed medical journals. Both laboratories are contracted with UnitedHealthcare.
UnitedHealthcare is encouraging laboratories that are continuing their HER2 testing programs to become certified as soon as possible and to make the results of the certification public.
For More Information on HER2 Testing and Herceptin, visit www.HER2support.org and www.HER2info.com.
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