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
CMDC, GM: Conceptualization, Data curation, Formal Analysis, Funding acquisition, Investigation, Methodology, Resources, Software, Supervision, Validation, Visualization, Writing—review & editing. VC, FC, TT, SN: Conceptualization, Data curation, Formal Analysis, Funding acquisition, Investigation, Methodology, Resources, Software, Project administration, Supervision, Validation, Visualization, Writing—original draft, Writing—review & editing.
The authors declare that they have no conflicts of interest.
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© The Author(s) 2023.