Table 1.
Summary of currently available biomarkers for use in prostate cancer detection or stratification.
| Name | Company | Molecular marker | FDA | Accuracy |
|---|---|---|---|---|
| Serum-based biomarkers | ||||
| ProPSA & Prostate Health Index | Beckman Coultier Inc., Brea, CA, USA | PSA Free PSA [2]proPSA |
Yes | AUC 0.703 Spec 16%, Sens 95% |
| 4K score test | OPKO Lab, Miami, FL, USA | Human Kallikrien Assay (fPSA, PSA, tPSA, hK2) |
No | AUC 0.82 |
| Urinary biomarkers | ||||
| Prostate cancer antigen 3 (Progensa) | Hologic, Marlborough, MA, USA | PCA3 | Yes | AUC 0.68–0.87 |
| TMPRSS2-ERG | N/A | TMPRSS2-ERG fusion | No | Sens 24.3–37%, Spec 93%, PPV 94% PCA3 + PSA + TMPRSS2-ERG-AUC 0.88 |
| ExoDx Prostate Intelliscore urine exosome assay | Exosome Diagnostics Inc, Cambridge, MA, USA | ERG, PCA3, & SPDEF | No | Sens 92%, Spec of 34%, NPV 91%, PPV 36%, AUC 0.77 |
| SChLAP1 | GenomeDx Biosciences, San Diego, CA, USA | SChLAP1 expression | No | In conjunction with Decipher, AUC 0.79 |
| SelectMDx | MDxHealth, Irvine, CA, USA | HOXC6 & DLX1 | No | Sens 91%, Spec 36%, NPV 94%, PPV 27%, AUC 0.76 |
| Prostatic tissue-based biomarkers | ||||
| ConfirmMDx | MDxHealth, Irvine, CA, USA | DNA methylation of GSTP1, APC, & RASSF1 genes | No | NPV 96% |
| Oncotype DX Prostate Cancer Assay | Genomic Health Inc., Redwood City, CA, USA | 12 cancer related genes, & 5 reference genes | No | Not reported |
| Prolaris score | Myriad Genomic Inc., Salt Lake City, UT, USA | 31 cell cycle progression genes | No | Not reported |
| Decipher | GenomeDx Biosciences, San Diego, CA, USA | 22 RNA biomarkers | No | AUC 0.79 |
| ELAVL1 | EnVision Kit; Dako, Glostrup, Denmark | Embryonic Lethal, Abnormal Vision, Drosophila-Like 1 (ELAVL1) expression | No | Not reported |
AUC, area under the curve; DNA, deoxyribonucleic acid; ELAVL1, Embryonic Lethal, Abnormal Vision, Drosophila-Like 1; NPV, negative predictive value; PCA3, prostate cancer antigen 3; PPV, positive predictive value; PSA, prostate specific antigen; RNA, ribonucleic acid; SChLAP1, Second Chromosome Locus Associated with Prostate-1; Sens, sensitivity; Spec, specificity; TMPRSS2-ERG, Transmembrane serine protease protein 2-Erythroblastosis virus E26 Oncogene Homolog.