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HER2 assays from FFPE

Wednesday 7 December 2011

The availability of drugs targeting the EGFR/HER/erbB signaling pathway has created a need for diagnostics that accurately predict treatment responses.

The selection of patients with HER2-positive breast cancer for treatment with trastuzumab is based on the measurement of HER2 protein expression by immunohistochemistry, or the presence of HER2 gene amplification by fluorescence in situ hybridization (FISH).

HER2 Assays

- quantitation of HER1 and HER2 total protein and homodimers in FFPE

- HER2 immunochemistry

  • Quantitative HER2 immunochemistry


- Selection of reference genes for normalization of qRT-PCR data derived from FFPE breast tumors. Drury S, Anderson H, Dowsett M. Diagn Mol Pathol. 2009 Jun;18(2):103-7. PMID: 19430294

- A novel proximity assay for the detection of proteins and protein complexes: quantitation of HER1 and HER2 total protein expression and homodimerization in formalin-fixed, paraffin-embedded cell lines and breast cancer tissue. Shi Y, Huang W, Tan Y, Jin X, Dua R, Penuel E, Mukherjee A, Sperinde J, Pannu H, Chenna A, DeFazio-Eli L, Pidaparthi S, Badal Y, Wallweber G, Chen L, Williams S, Tahir H, Larson J, Goodman L, Whitcomb J, Petropoulos C, Winslow J. Diagn Mol Pathol. 2009 Mar;18(1):11-21. PMID: 19214113

- Quantitation of HER2 expression or HER2:HER2 dimers and differential survival in a cohort of metastatic breast cancer patients carefully selected for trastuzumab treatment primarily by FISH. Desmedt C, Sperinde J, Piette F, Huang W, Jin X, Tan Y, Durbecq V, Larsimont D, Giuliani R, Chappey C, Buyse M, Winslow J, Piccart M, Sotiriou C, Petropoulos C, Bates M. Diagn Mol Pathol. 2009 Mar;18(1):22-9. PMID: 19214112

- Real time RT-PCR approach for the evaluation of ERBB2 overexpression in breast cancer archival samples: a comparative study with FISH, SISH, and immunohistochemistry. Capizzi E, Gruppioni E, Grigioni AD, Gabusi E, Grassigli A, Grigioni WF, Fiorentino M. Diagn Mol Pathol. 2008 Dec;17(4):220-6. PMID: 18382352