Table 5 Characteristics of commercially approved platforms for ctDNA

Allelic-specific PCR

Cobas EGFR mutation Test v2®

Real-time PCR

DNA derived from FFPE tissue or cfDNA from plasma

42 EGFR mutations in exons 18, 19, 20, 21

FDA approval for detection

of EGFR del19, EGFR L858R, and EGFR T790M; FDA, Jun and Sept, 2016 [67]

Therascreen® EGFR Plasma RGQ PCR kit

Real-time PCR

cfDNA from plasma

29 EGFR mutations in exons 19, 20, 21

E.U. approval for detection of EGFR del19 and

EGFR L858R;

EMA, Jan 2015 [78]

AmoyDx Super-ARMS® EFGR mutation test kit

Real-time PCR

Compatible with FFPE tissue or plasma/serum samples

41 EGFR mutations in exons 18–21, including L858R, exon 19 deletions, and T790M

Chinese FDA approval for detection of EGFR del19,

EGFR 858R, and EGFR T790M

China FDA. Jan 2018 [79]

NGS

Guardant360 CDx®

Targeted hybridization-based capture technology

cfDNA

73-gene panel

(single nucleotide variants (SNVs), insertions and deletions (indels) in 55 genes, copy number amplifications (CNAs) in two [2] genes, and fusions in four [4] genes

FDA, Nov 2016 [122] to identify NSCLC patients who may benefit from treatment with the targeted therapies in accordance with the approved therapeutic products labelling

FoundationOne Liquid CDx®

Targeted hybridization-based capture technology

cfDNA

311 genes panel including substitutions, insertions and deletions (indels), rearrangements and copy number losses only in BRCA1 and BRCA2

US FDA, August 2020 [149] to identify NSCLC patients who may benefit from treatment with the targeted therapies in accordance with the approved therapeutic products labelling