Table 1.

FDA approvals of circulating tumor DNA-based companion diagnostics

Device	Cancer type	CDx biomarker(s)	Drug(s)
Cobas EGFR Mutation Test v2 PCR test	NSCLC	EGFR exon 19 deletions or exon 21 L858R mutations	Group labeling claim for FDA approved TKIs Tarceva (erlotinib), Tagrisso (osimertinib, Iressa (gefitinib)
		Exon 20 T790M substitution mutation	Tagrisso (osimertinib)
therascreen PIK3CA RGQ PCR Kit PCR test	Breast Cancer	11 mutations in PIK3CA	Piqray (alpelisib)
Guardant360 CDx Test NGS test	NSCLC	EGFR exon 19 deletions, L858R, and T790M	Tagrisso (osimertinib)
		EGFR exon 20 insertions	Rybrevant (amivantamab-vmjw)
		KRAS G12C	Lumakras (sotorasib)
F1 Liquid CDx Test NGS test	NSCLC	EGFR exon 19 deletions, L858R	Iressa (gefitinib), Tagrisso (osimertinib), Tarceva (erlotinib)
		MET exon 14 SNVs and indels lead to skipping	Tabrecta (capmatinib)
		ALK	Alecensa (alectinib)
	Prostate Cancer	BRCA1, BRCA2	Rubraca (rucaparib)
		BRCA1. BRCA2, ATM	Lynparza (olaparib)
	Ovarian Cancer	BRCA1, BRCA2	Rubraca (rucaparib)
	Breast Cancer	11 mutations in PIK3CA	Piqray (alpelisib)

CDx, companion diagnostic; FDA, Food and Drug Administration; indel, insertion-deletion; NGS, next generation sequencing; NSCLC, non-small cell lung cancer; SNV, single-nucleotide variant; TKI, tyrosine kinase inhibitor.