Table 1.
Type of “liquid biopsy” | Source | Methods of isolation | FDA-approved assays | Sensitivity of available assays | Specificity of available assays |
---|---|---|---|---|---|
Circulating tumor cells (CTCs) | Shed from primary tumors | Epithelial cell adhesion molecule (EpCAM)-independent or EpCAM-dependent assays | None yet approved | 23–90% (detection rates) | N/A |
Cell-free nucleic acid (cfNA) | Passive release from apoptosis/necrosis or active secretion; from both tumor and healthy cells | Many extraction kits with further enrichment using digital droplet PCR (ddPCR) or next generation sequencing (NGS) | cobas EGFR Mutation Test v2‡ (assesses for EGFR sensitizing mutations) | 15–100% | 89–100% |
Extracellular vesicles (EVs) | Membranous lipid structures secreted by both tumor and healthy cells | Differential ultra-centrifugation (gold standard); assays not needing special equipment to isolate EVs based on their physical properties are also available | None yet approved | N/A (technology still being developed) | N/A (technology still being developed) |
Urine cfNA | cfNA that is either filtered by the kidney or from cells that came into direct contact with urine | Extraction kits with further enrichment through ddPCR or NGS as in plasma cfNA | None yet approved | 81–100% (Concordance rates) | N/A |
Myriad Genetics
Roche