Cell Lines as Candidate Reference Materials for Quality Control of ERBB2 Amplification and Expression Assays in Breast Cancer | Zendy

Xiao Yan | Zendy; Xiugong Gao | Zendy; Samantha Maragh | Zendy; William G. Telford | Zendy; Alessandro Tona | Zendy

Open Access

Cell Lines as Candidate Reference Materials for Quality Control of ERBB2 Amplification and Expression Assays in Breast Cancer

Author(s) -

Xiao Yan,

Xiugong Gao,

Samantha Maragh,

William G. Telford,

Alessandro Tona

Publication year - 2009

Publication title -

clinical chemistry

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.705

H-Index - 218

eISSN - 1530-8561

pISSN - 0009-9147

DOI - 10.1373/clinchem.2008.120576

Subject(s) - immunohistochemistry , fluorescence in situ hybridization , microbiology and biotechnology , breast cancer , mcf 7 , biomarker , reference genes , biology , cancer , biotinylation , human epidermal growth factor receptor 2 , cell culture , cancer research , gene expression , gene , chromosome , immunology , genetics , human breast

Human epidermal growth factor receptor 2 (HER2) is an important biomarker whose status plays a pivotal role in therapeutic decision-making for breast cancer patients and in determining their clinical outcomes. Ensuring the accuracy and reproducibility of HER2 assays by immunohistochemistry (IHC) and by fluorescence in situ hybridization (FISH) requires a reliable standard for monitoring assay sensitivity and specificity, and for assessing methodologic variation. A prior NIST workshop addressed this need by reaching a consensus to create cell lines as reference materials for HER2 testing.

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