Table 1.
Examples of FDA-approved commercial tests for clinical application of ctDNA liquid biopsy
| Test | Manufacturer | Cancer type indications | Biomarker (single cancer indication, pan-cancer/multi-cancer indications) | Technology |
|---|---|---|---|---|
| Therascreen®, PIK3CA RGQ PCR Kit | Qiagen Manchester, Ltd. |
Companion diagnostic Breast cancer: piqray (alpelisib) |
PIK3CA | PCR |
| Cobas EGFR mutation Test v2 | Roche Molecular Systems, Inc. |
Companion diagnostic NSCLC: tarceva (erlotinib), tagrisso (osimertinib), iressa (gefitinib) |
EGFR | PCR |
| Epi ProColon® | Epigenomics AG | Ancillary screening: colorectal cancer | SEPT9 methylation | Bisulfite converted DNA and PCR |
| Guardant360® CDx | Guardant Health, Inc. |
Companion diagnostic NSCLC: tagrisso (osimertinib), rybrevant (amivantamab-vmjw), lumakras (sotorasib) |
EGFR | NGS |
| FoundationOne® Liquid CDx | Guardant Health, Inc. | Tumor mutation profiling: any solid tumor | 73 genes | |
| FoundationOne® Liquid CDx | Foundation Medicine, Inc. |
Companion diagnostic NSCLC: iressa (gefitinib), tagrisso (osimertinib), tarceva (erlotinib), alecensa (alectinib), tabrecta (capmatinib) Metastatic castrate resistant prostate cancer (mCRPC): rubraca (rucaparib), lynparza (olaparib) Ovarian cancer: rubraca (rucaparib) Breast cancer: piqray (alpelisib) |
EGFR, ALK BRCA1/2, ATM BRCA1/2, PIK3CA | NGS |
| Tumor mutation profiling: any solid tumor | 324 genes | |||
| BRAC Analysis CDx | Myriad Genetic Laboratories, Inc. |
Companion diagnostic Breast cancer: lynparza (olaparib), talzenna (talazoparib) Ovarian cancer: lynparza (olaparib), rubraca (rucaparib) Pancreatic cancer: lynparza (olaparib) mCRPC: lynparza (olaparib) |
BRCA | PCR |
The table illustrates the characteristics of some FDA-approved commercial tests as companion diagnostic tests and as ancillary screening tests for the ctDNA liquid biopsy. PIK3CA: phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; RGQ: rotor-gene Q; EGFR: epidermal growth factor receptor; SEPT9: septin 9; ALK: anaplastic lymphoma kinase; BRCA: breast cancer susceptibility genes; ATM: ataxia- telangiectasia mutated