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.