PMID- 30087576 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220318 IS - 1179-1314 (Print) IS - 1179-1314 (Electronic) IS - 1179-1314 (Linking) VI - 10 DP - 2018 TI - Single-day HER2neu amplification assessment using chip-based digital PCR in formalin-fixed paraffin-embedded breast carcinoma tissue. PG - 121-129 LID - 10.2147/BCTT.S161264 [doi] AB - INTRODUCTION: 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). MATERIALS AND METHODS: A total of 84 breast carcinoma tissue samples were analyzed by IHC, FISH, and chip-based dPCR in a blinded manner. RESULTS: 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. CONCLUSION: 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. FAU - Shah, Parth S AU - Shah PS AD - Department of Molecular Genetics, Supratech Micropath Laboratory and Research Institute, Ahmedabad, India, shiva.murarka@supratechlabs.com. AD - Department of Medicine, Lahey Hospital and Medical Center, Burlington, MA, USA. FAU - Murarka, Shiva AU - Murarka S AD - Department of Molecular Genetics, Supratech Micropath Laboratory and Research Institute, Ahmedabad, India, shiva.murarka@supratechlabs.com. FAU - Joshi, Anupam AU - Joshi A AD - Department of Histopathology, Supratech Micropath Laboratory and Research Institute, Ahmedabad, India. FAU - Mehta, Bhavna AU - Mehta B AD - Department of Histopathology, Supratech Micropath Laboratory and Research Institute, Ahmedabad, India. FAU - Parmar, Vipal AU - Parmar V AD - Department of Histopathology, Supratech Micropath Laboratory and Research Institute, Ahmedabad, India. FAU - Shah, Nidhi AU - Shah N AD - Department of Molecular Genetics, Supratech Micropath Laboratory and Research Institute, Ahmedabad, India, shiva.murarka@supratechlabs.com. AD - Department of Pediatrics, Nassau University Medical Center, East Meadow, NY, USA. FAU - Patel, Khushbu AU - Patel K AD - Department of Molecular Genetics, Supratech Micropath Laboratory and Research Institute, Ahmedabad, India, shiva.murarka@supratechlabs.com. FAU - Sands, Jacob AU - Sands J AD - Department of Hematology and Oncology, Lahey Hospital and Medical Center, Burlington, MA, USA. LA - eng PT - Journal Article DEP - 20180723 PL - New Zealand TA - Breast Cancer (Dove Med Press) JT - Breast cancer (Dove Medical Press) JID - 101591856 PMC - PMC6061198 OTO - NOTNLM OT - FISH OT - HER2 OT - IHC OT - breast cancer OT - digital PCR COIS- Disclosure The authors report no conflicts of interest in this work. EDAT- 2018/08/09 06:00 MHDA- 2018/08/09 06:01 PMCR- 2018/07/23 CRDT- 2018/08/09 06:00 PHST- 2018/08/09 06:00 [entrez] PHST- 2018/08/09 06:00 [pubmed] PHST- 2018/08/09 06:01 [medline] PHST- 2018/07/23 00:00 [pmc-release] AID - bctt-10-121 [pii] AID - 10.2147/BCTT.S161264 [doi] PST - epublish SO - Breast Cancer (Dove Med Press). 2018 Jul 23;10:121-129. doi: 10.2147/BCTT.S161264. eCollection 2018.