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. 2023 Nov 27;15(23):5607. doi: 10.3390/cancers15235607

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.