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Table 5 Characteristics of commercially approved platforms for ctDNA

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

Methodology Assay Technique Sample Gene Spectrum Approved indications
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
  1. FDA Food and Drug Administration, FFPE Formalin-fixed paraffin-embedded