Table 6. Performance characteristics of ExoDx Prostate Intelliscore (EPI) in predicting GG ≥2 prostate cancer by population and biopsy status.
| ExoDx Prostate Intelliscore (EPI) Studies | Population | Bx status | N | GG ≥2 (%) | Cutoff value | Sn (%) | Sp (%) | NPV (%) | PPV (%) | Bx avoided (%) | Unnecessary Bx avoided (%) | GG ≥2 missed (%) | Model used |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| McKiernan et al., 2016 (58) | PSA 2-20 | Bx-naïve | 519 | 29 | 15.6 | 92 | 34 | 91 | 36 | 27 | 34* | 8 | Full EPI |
| McKiernan et al., 2018 (59) | PSA 2-20 | Bx-naïve | 503 | 31 | 15.6 | 93 | 26 | 89 | 37 | 20 | 26 | 7 | Full EPI |
| 20 | 89 | 40 | 89 | 41 | 31 | 40 | 11 |
Bx, biopsy; RBx, repeat biopsy; Sn, sensitivity; Sp, specificity; NPV, negative predictive value; PPV, positive predictive value; PSA, ng/mL; EXO106 model, PCA3 and ERG; Full EPI, PCA3, ERG, and SPDEF; PCA3, prostate cancer antigen 3; ERG, ETS transcription factor ERG; SPDEF, SAM pointed domain-containing ETS transcription factor. Calculated values are labeled with an asterisk (*).