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Table 2 ctDNA plasma detection of EGFR mutation

From: The value of cell-free circulating tumour DNA profiling in advanced non-small cell lung cancer (NSCLC) management

Reference Method of detection Study type/ Sample size Sensitivity/ PPA Specificity/NPA Concordance/ OPA between tissue and liquid biopsy
Douillard J et al. [65] QUIAGEN therascreen® EGFR RGQ PCR Kit Prospective, single-arm phase IV study (IFUM study); N = 652 65.7% 99.8% 94.3%
Reck M et al. [54] QUIAGEN therascreen® EGFR RGQ PCR Kit; Cobas® EGFR mutations test version 2; Cycleave®; PNA-LNA PCR Clamp; other Multicenter (ASSESS study); N = 1162 46% 97% 89%
Han B et al. [55] Cobas® EGFR mutations test version 2 Multicenter (IGNITE study); N = 2561 46.9% 95.6% 80.5%
Wu YL et al. [148] QUIAGEN therascreen® EGFR RGQ PCR Kit Phase III, Prospective (Lux-Lung 3 and 6 studies); N = 334 (plasma); N = 287 (serum) 60.5% (plasma)
28.6% (serum)
n.r n.r
Jenkins et al. [74] Cobas® EGFR Mutation Test v2 AURA extension and AURA2 phase II studies; N = 210 T790M: 61%
L858R: 76%
Del19: 91%
T790M: 79%
L858R: 98%
Del19: 98%
T790M: 65%
L858R: 85%
Del19: 90%
Oxnard et al. [76] BEAMing (Sysmex®) Retrospective (AURA phase I)
N = 216
T790M: 70%
L858R: 86%
Del19: 82%
T790M: 69%
L858R: 97%
Del19: 98%
n.r
Karlovich et al. [73] Cobas® EGFR mutations test; BEAMing (Symex® Inostics GmbH) Prospective, multicentre, observational and phase-1 TIGER-X; N = 153 (Cobas/BEAMING)
Activating mutations: 73%/82%
T790M: 64%/73%
(Cobas/BEAMING)
Activating mutations: 100%
T790M: 98%/50%
(Cobas/BEAMING)
Activating mutations: 80%
T790M: 86%/67%
Sacher et al. [56] Droplet digital PCR (ddPCR) Prospective; N = 180 (120 newly diagnosed + 60 acquired resistance) Del19: 82%
L858R: 74% T790M: 77%
Del19:100% L858R: 100% T790M: 63% Del19: 91%
L858R: 80%
T790M: 40%
Zheng D et al. [57] Droplet digital PCR (ddPCR) N = 117 T790M: 81% T790M: 100% 88%
  1. PPA Positive percent agreement, NPA Negative percent agreement, OPA overall percent agreement, n.r. not reported