A comparison of ARMS-Plus and droplet digital PCR for detecting EGFR activating mutations in plasma
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Xinxin Zhang1,*, Ning Chang1,*, Guohua Yang3, Yong Zhang1, Mingxiang Ye1, Jing Cao1, Jie Xiong1, Zhiping Han1, Shuo Wu1, Lei Shang2 and Jian Zhang1
1Department of Pulmonary Medicine, Xijing Hospital, Fourth Military Medical University, Xi’an, China
2Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, China
3Research and Development Department, GenoSaber Biotech Co. Ltd., Shanghai, China
*These authors have contributed equally to this work
Jian Zhang, email: firstname.lastname@example.org
Keywords: NSCLC; EGFR; liquid biopsy
Received: December 28, 2016 Accepted: June 02, 2017 Published: December 06, 2017
In this study, we introduce a novel amplification refractory mutation system (ARMS)-based assay, namely ARMS-Plus, for the detection of epidermal growth factor receptor (EGFR) mutations in plasma samples. We evaluated the performance of ARMS-Plus in comparison with droplet digital PCR (ddPCR) and assessed the significance of plasma EGFR mutations in predicting efficacy of EGFR-tyrosine kinase inhibitor (TKI) regimen. A total of 122 advanced non-small cell lung cancer (NSCLC) patients were enrolled in this study. The tumor tissue samples from these patients were evaluated by conventional ARMS PCR method to confirm their EGFR mutation status. For the 116 plasma samples analyzed by ARMS-Plus, the sensitivity, specificity, and concordance rate were 77.27% (34/44), 97.22% (70/72), and 89.66% (104/116; κ=0.77, P<0.0001), respectively. Among the 71 plasma samples analyzed by both ARMS-Plus and ddPCR, ARMS-Plus showed a higher sensitivity than ddPCR (83.33% versus 70.83%). The presence of EGFR activating mutations in plasma was not associated with the response to EGFR-TKI, although further validation with a larger cohort is required to confirm the correlation. Collectively, the performance of ARMS-Plus and ddPCR are comparable. ARMS-Plus could be a potential alternative to tissue genotyping for the detection of plasma EGFR mutations in NSCLC patients.
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