Abstract 5891: Plasma-based BDA-NGS test holds potential in circulating nucleic acid based oncogenic aberration detection
Authors: Ren Shengxiang , Mao Shiqi , Yang Shuo , Liu Yiwei , Li Xuefei , Zhao Chao , Gao Guanghui , Li Wei , Xiong Anwen , He Yayi , Wu Fengying , Chen Xiaoxia , Su Chunxia , Zhou Caicun , Zhang David Yu , Hirsch Fred R. 
Published: September 2020

Abstract
Introduction:
Liquid biopsy has been increasingly acknowledged as a substitute of invasive tissue biopsies in the era of targeted therapies, with the booming of plasma-based test platforms. However, the optimal platform for liquid biopsy has not come to a consensus yet and no approved platforms have been approved for oncogene fusion detection. This study aimed to investigate the feasibility of BDA-NGS in plasma-based molecular detection for patients with advanced NSCLC.
Methods:
This was a preliminary study. 20 paired tissue and blood samples from untreated advanced NSCLC patients underwent molecular detection, using ARMS-PCR (Amoy Diagnostics Co, Ltd) for tissue samples and BDA-NGS (Carrier Gene Biotech Co, Ltd) for blood samples. Specificity, sensitivity and consistency were calculated and compared. Statistical analysis was performed with SAS (version 16.0).
Results:
Among 20 paired samples, tissue-based ARMS-PCR identified 13 oncogene aberrations, including 11 EGFR mutations, 1 ALK fusion and 1 KRAS mutation. While, plasma-based BDA-NGS also identified 13 oncogene aberrations, including 11 EGFR mutations, 1 ALK fusion and 2 KRAS mutations. The specificity of plasma-based BDA-NGS was 92.3%, sensitivity was 85.7% and consistency was 90.0%, when compared with tissue-based AMRS-PCR. Plasma-based BDA-NGS also identified one EGFR 19del from wild type EGFR and one KRAS co-mutation from ALK fusion by tissue-based ARMS-PCR. However, one patient confirmed as EGFR G719X by tissue-based ARMS-PCR was identified as EGFR wild type by plasma-based BDA-NGS. Since plasma-based BDA-NGS successfully identified ALK fusion, we then mainly focus on the feasibility of BDA-NGS in oncogene fusion detection, results shall be reported lately.
Conclusion:
Plasma-based BDA-NGS demonstrated high concordant detection rate compared with tissue-based tests, also further increased the detection of oncogene aberrations. The feasibility of plasma-based BDA-NGS in oncogene fusion detection are under evaluation, results shall be reported in the near future.
Molecular detection according to different testsNo.AgeGenderHistologytissue-based ARMS-PCRplasma-based BDA-NGS#132FadenocarcinomaWTWT#264FadenocarcinomaL858R + S768IL858R + S768I#355FadenocarcinomaWT19DEL#466Fadenocarcinoma19DEL19DEL#567FNSCLC-NOSWTWT#653Madenocarcinoma19DEL19DEL#757MadenocarcinomaKRASKRAS#874MadenocarcinomaWTWT#962MNSCLC-NOSWTWT#1081FadenocarcinomaL858RL858R#1171MNSCLC-NOSWTWT#1267MadenocarcinomaL858RL858R#1385Msquamous carcinomaWTWT#1449FadenocarcimonaG719XWT#1567MadenocarcinomaL858RL858R#1659FadenocarcinomaL858RL858R#1738MNSCLC-NOSALK fusionKRAS + ALK fusion#1866Msquamous carcinoma19DEL19DEL#1954MadenocarcinomaL858RL858R#2070MadenocarcinomaL858RL858R
Citation Format: Shengxiang Ren, Shiqi Mao, Shuo Yang, Yiwei Liu, Xuefei Li, Chao Zhao, Guanghui Gao, Wei Li, Anwen Xiong, Yayi He, Fengying Wu, Xiaoxia Chen, Chunxia Su, Caicun Zhou, David Yu Zhang, Fred R. Hirsch. Plasma-based BDA-NGS test holds potential in circulating nucleic acid based oncogenic aberration detection [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 5891.