Examples of FDA-approved commercial tests for clinical application of ctDNA liquid biopsy

TestManufacturerCancer type indicationsBiomarker (single cancer indication, pan-cancer/multi-cancer indications)Technology
Therascreen®, PIK3CA RGQ PCR KitQiagen Manchester, Ltd.

Companion diagnostic

Breast cancer: piqray (alpelisib)

PIK3CAPCR
Cobas EGFR mutation Test v2Roche Molecular Systems, Inc.

Companion diagnostic

NSCLC: tarceva (erlotinib), tagrisso (osimertinib), iressa (gefitinib)

EGFRPCR
Epi ProColon®Epigenomics AGAncillary screening: colorectal cancerSEPT9 methylationBisulfite converted DNA and PCR
Guardant360® CDxGuardant Health, Inc.

Companion diagnostic

NSCLC: tagrisso (osimertinib), rybrevant (amivantamab-vmjw), lumakras (sotorasib)

EGFRNGS
FoundationOne® Liquid CDxGuardant Health, Inc.Tumor mutation profiling: any solid tumor73 genes
FoundationOne® Liquid CDxFoundation 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, PIK3CANGS
Tumor mutation profiling: any solid tumor324 genes
BRAC Analysis CDxMyriad Genetic Laboratories, Inc.

Companion diagnostic

Breast cancer: lynparza (olaparib), talzenna (talazoparib)

Ovarian cancer: lynparza (olaparib), rubraca (rucaparib)

Pancreatic cancer: lynparza (olaparib)

mCRPC: lynparza (olaparib)

BRCAPCR

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