Circulating tumor nucleic acids: biology, release mechanisms, and clinical relevance

Table 1 Approved diagnostic tests for detecting altered genes in cfDNA

Test	Approval	Cancer type	Analyte	Technology	Target
Cobas^® EGFR Mutation Test v2 [6, 185]	FDA, EMA	Non-small cell lung	Blood (cfDNA), tissue DNA (FFPE)	RT-PCR	EGFR gene
FoundationOne^® Liquid CDx [10]	FDA	Multiple	Blood (cfDNA)	NGS	Panel (300 genes)
Guardant360 CDx [186]	FDA	Multiple	Blood (cfDNA)	NGS	Panel (55 genes)
Qiagen therascreen PIK3CA RGQ PCR Kit [187]	FDA	Breast (selection of patients eligible for treatment with alpha-selective PIK3-inhibitor alpelisib)	Blood (cfDNA), tissue DNA (FFPE)	RT-PCR	PIK3CA gene
Epi proColon^® [188]	FDA	Colorectal	Blood (cfDNA)	RT-PCR	Methylated SEPT9 gene

FDA Food and Drug Administration, EMA European Medicines Agency, RT-PCR real-time PCR, NGS Next generation sequencing

ISSN: 1476-4598