Table 3.
FDA-approved liquid biopsy tests for companion diagnostics.
| Companion Diagnostic Test |
Drugs | Disease Type/ Sample Type |
Mutation | Technique for Mutation Detection |
Manufacturer |
|---|---|---|---|---|---|
| cobas EGFR mutation test |
erlotinib (Tarceva), osimertinib (Tagrisso), gefitinib (Iressa) |
NSCLC/plasma |
EGFR mutations (exon 19 deletions, L858R mutation), T790M mutation |
Real time polymerase chain reaction (RT-PCR) | Roche |
| Guardant 360 CDx | osimertinib (Tagrisso) | NSCLC/lasma | EGFR mutation | Next-generation sequencing |
Guardant |
| amivantamab (Rybrevant) |
EGFR mutation (exon 20 mutation) |
||||
| FoundationOne Liquid CDx |
rucaparib (Rubarca) | Ovarian cancer/plasma | BRCA1, BRCA2 | Next-generation sequencing |
Foundation One |
| alectinib (Alecensa) | NSCLC | ALK rearrangement | |||
| alpelsib (Piqray) | Breast cancer | PIK3CA | |||
| olaparib (Lynparza) | mCRPC/plasma | BRCA1, BRCA2, ATM | |||
| rucaparib (Rubarca), AR-directed therapy, Taxane |
mCRPC/plasma | BRCA1, BRCA2 | |||
| gefitinib (Iressa), osimertinib (Tagrisso), erlotinib (Tarceva) |
Lung cancer |
EGFR mutations (exon 19 deletions, L858R mutation) |
|||
| capmatinib (Tabrecta, Novartis) |
NSCLC |
MET (exon 14 mutations) |
|||
| therascreen PIK3CA RGQ PCR Kit | alpelsib (Piqray) | Breast cancer/plasma | PIK3CA | Real-time polymerase chain reaction (RT-PCR) | Qiagen GmbH |
| ArcherDx’s ArcherMET Assay |
tepotinib (Tepmetko, Merck KGaA) |
NSCLC/plasma |
MET (exon 14 skipping) |
Next-generation sequencing |
Archer |