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April 28, 2004

High-Quality HER-2 TestingSetting a Standard for Oncologic Biomarker Assessment

Author Affiliations

Author Affiliation: Division of Surgical Pathology, Northwestern University Medical School, Chicago, Ill.

JAMA. 2004;291(16):2019-2020. doi:10.1001/jama.291.16.2019

In this issue of THE JOURNAL, Yaziji and colleagues1 report the results from an elegant study that should help to inform the ongoing debate over a controversial topic, determining the optimal testing strategy for assessing HER-2 status in breast cancer. The human epidermal growth factor receptor 2, HER-2 (HER-2/neu or c-erbB-2), is a biomarker that is overexpressed in approximately 20% to 30% of invasive breast cancers.2,3 Since the introduction of the humanized anti–HER-2 antibody (trastuzumab) into clinical therapeutic use in 1998, a heated debate has ensued over the optimal testing strategy for HER-2 status for patients with breast cancer. At the heart of this debate is the issue of which specific testing method is better for the prediction of response to treatment, immunohistochemistry or fluorescence in situ hybridization (FISH). This controversy has been heightened in the wake of published studies demonstrating poor concordance for HER-2 testing between reference and community-based laboratories.4,5

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