Table 1.
List of FDA-approved single biomarkers for detection of EOC.
| Criteria | Value/ Target Cohort |
Biomarkers | |||
|---|---|---|---|---|---|
| CA125 U/mL | HE4 pM/L | CA19-9 U/mL | CEA ng/mL | ||
| Type | Mucinous Glycoprotein |
Glycoprotein | Mucinous Glycoprotein |
Glycoprotein | |
| Diagnostic | ✓ | ✓ | ✓ | ✓ | |
| Prognosis | ✓ | ✓ | ✓ | ||
| Monitoring | ✓ | ✓ | |||
| FDA Approval (Year) | 1981 | 2008 | 2002 | 1985 | |
| Cut-off | 35 | >70 or 140 | <37 or 27 | 2.5–5 | |
| MW (kDa) | >200 | 25 | 1000 | 180 | |
| Immunoassay Technique: ECLIA/Magnetic bead assay |
SP% | >60–80 | >96–100 | 79.01 | >88–100 |
| SN% | >60–96 | >63–83 | 35.71 | >38–66.3 | |
| Benign | 9.02–54.92 | 49.01–54.49 | 19.15 | 2.71 | |
| Malignant | 368 | 245.9 | |||
| Late-stage | 184.62 | 234.77 | 45.61 | 9.27 | |
| Ref. | [60,61] | [60,61,62,63] | [36,54,64] | [52,64,65,66] | |
Abbreviations: CA 125: cancer antigen 125; HE4: human epididymis secretory protein 4; CA19-9: carbohydrate antigen 19-9; CEA: carcinoembryonic antigen; FDA: Food and Drug Administration; MW: Molecular weight; ECLIA: Electrochemiluminescence Immunoassay; SP%: Specificity; SN%: Sensitivity. ✓-Used as biomarker.