Single-day HER2neu amplification assessment using chip-based digital PCR in formalin-fixed paraffin-embedded breast carcinoma tissue

Human epidermal growth factor receptor 2 (HER2) amplification is present in almost 15%-20% of breast cancer tumors, making it an important parameter for testing. The present study was designed to evaluate a chip-based digital PCR (dPCR) system for assessing HER2 amplification from formalin-fixed par...

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Published inBreast cancer targets and therapy Vol. 10; pp. 121 - 129
Main Authors Shah, Parth S, Murarka, Shiva, Joshi, Anupam, Mehta, Bhavna, Parmar, Vipal, Shah, Nidhi, Patel, Khushbu, Sands, Jacob
Format Journal Article
LanguageEnglish
Published New Zealand Taylor & Francis Ltd 01.01.2018
Dove Medical Press
Subjects
Breast cancer
Cytogenetics
Deoxyribonucleic acid
digital PCR
DNA
Epidermal growth factor
FISH
Gene amplification
HER2
Histopathology
Hybridization
IHC
Medical research
Original Research
Quality control
Reference materials
Testing laboratories
Tumors
United States > US
India
FISH
breast cancer
digital PCR
HER2
IHC
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Summary:Human epidermal growth factor receptor 2 (HER2) amplification is present in almost 15%-20% of breast cancer tumors, making it an important parameter for testing. The present study was designed to evaluate a chip-based digital PCR (dPCR) system for assessing HER2 amplification from formalin-fixed paraffin-embedded breast carcinoma tissue and to compare this system with immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). A total of 84 breast carcinoma tissue samples were analyzed by IHC, FISH, and chip-based dPCR in a blinded manner. All nine IHC-positive and 35 IHC-negative samples had equivalent results with dPCR, taking an amplification ratio threshold of 1.8 as a positive result. Of the 40 IHC equivocal samples, 10 were assessed as positive, 27 as negative, and three as equivocal by dPCR. These results demonstrate that chip-based dPCR is suitable for HER2 amplification detection in formalin-fixed paraffin-embedded samples in a clinical setting, providing the advantages of superior turnaround time, cost-effectiveness, and increased precision with absolute quantification compared with conventional tests such as FISH and IHC. This methodology was especially beneficial in tissue samples with low DNA concentration.
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ISSN:1179-1314
1179-1314
DOI:10.2147/BCTT.S161264