Table 2.
List of FDA-approved biomarker-based multivariate Index assays for detection of EOC.
| ROMA Test | RMI | OVA1 Test | OVA2 (Overa) | |
|---|---|---|---|---|
| FDA Approval (Year) | 2011 | N/A | 2009 | 2016 |
| Biomarker | ||||
| • CA 125 | x | x | x | x |
| • HE4 | x | x | ||
| • B2M | x | |||
| • ApoA-I | x | x | ||
| • FSH | x | |||
| • TRF | x | |||
| • Transferrin | x | x | ||
| Immunoassay technique |
ECLIA [Cobas 8000, Roche Diagnostics Scandinavia AB, Sweden]// Magnetic bead assay [xMAP bead-based technology (Luminex, Austin, Texas)] |
ECLIA Cobas 6000 (Roche, Germany) /IVDMIA [Quest Diagnostics Incorporated; Vermillion, (Austin, Texas)] |
IVDMIA [Quest Diagnostics Incorporated; Vermillion, (Austin, Texas)] |
|
| SP (%) | >80 to 91 | >80 to 90 | <75 to 26 | 28–35 |
| SN (%) | >85 to 97 | >87 to 97 | >78 to 98 | 77–96 |
| Ref. | [40,52,60,65,67] | [40,52,60,65,67] | [36,44,52,54,60] | [52,60,66] |
Abbreviations: ROMA: Risk of Ovarian Malignancy Algorithm; Risk of Malignancy Index (RMI); FDA: Food and Drug Administration; CA 125: cancer antigen 125; HE4: human epididymis secretory protein 4; B2M: β2-microglobulin; ApoA-I: Apolipoprotein AI; FSH: follicle-stimulating hormone; Transthyretin (TRF); ECLIA: Electrochemiluminescence Immunoassay IVDMIA: In Vitro Diagnostic Multivariate Index Assay SP: Specificity; SN: Sensitivity. N/A: Not applicable; no data show the FDA approval year for RMI. The ‘x’ symbol indicates the inclusion of a biomarker in the ROMA test, RMI, OVA1 test, and OVA3 (Overa).