FDA-approved liquid biopsy CDx testing for NSCLC treatment

Name of testMutationDrugsTechnologyLimit of detection
Cobas EGFR mutation test v2EGFR exon 19 deletion
EGFR L858R
EGFR T790M
EGFR uncommon mutations		Gefitinib, erlotinib, osimertinibRT-PCR5% [7]
Gurdant 360 CDxEGFR mutations
EGFR exon 20 insertion
KRAS Gly12Cys		Osimertinib, amivantamab, sotorasibNGS panel (61 genes)0.25% [8]
1.50% (package insert)
FoundationOne Liquid CDxEGFR mutations (exon 19 deletion, L858R)
ALK fusion
MET exon 14 skipping		Gefitinib, erlotinib, osimertinib, alectinib, capmatinibNGS panel (318 genes)0.27∼0.94% [9]
ArcherMETMET exon 14 skippingTepotinibNGS0.20% (package insert) [10]

RT-PCR: reverse transcription polymerase chain reaction