Table 2:
Available Biomarker Assays
| Test | Biomarker Component | Clinical Variable | Biopsy Population |
|---|---|---|---|
| Serum | |||
| 4Kscore | PSA, fPSA, iPSA, hK2 | Age, prior biopsy status, DRE (optional) | Initial biopsy Repeat biopsy |
| IsoPSA* | All PSA isoforms | None | Not specified |
| Proclarix | THBS1, CTSD, PSA, fPSA | Age, prostate volume (optional) | Mixed |
| PHI | p2PSA, fPSA, PSA | None | Initial biopsy Repeat biopsy |
| STHLM-3 | 232 genetic polymorphisms (SNPs), PSA, fPSA, iPSA, hK2, MSMB, MIC1 | Age, family history, previous biopsy, DRE (optional) | Mixed |
| Post-DRE Urine | |||
| PCA3 | PCA3 | Some studies add age, PSA, prostate volume | Initial biopsy Repeat biopsy |
| MPS | PCA3, TMPRSS2:ERG, PSA | None | Initial biopsy Repeat biopsy |
| SelectMDx | HOXC6, DLX1 mRNA | Age, PSA, prostate volume, DRE | Initial biopsy |
| TMPRSS2:ERG | TMPRSS2:ERG | None | Initial biopsy |
| Urine | |||
| ExoDx Prostate Intelliscore | PCA3, ERG, SPDEF mRNA | None | Initial biopsy Repeat biopsy |
| MiR Sentinel | Small non-coding RNAs | None | Mixed |
| Tissue | |||
| Confirm MDx | Hypermethylation of GSTP1, APC, RASSF1 | None | Repeat biopsy |
(Abbreviations: DRE, digital rectal exam; fPSA, free PSA; iPSA, intact PSA; mRNA, messenger ribonucleic acid; PSA, prostate-specific antigen; SNP, single-nucleotide polymorphism.)
IsoPSA was not included in the initial literature search; however, it was identified on a secondary targeted search and included here for completeness.
Note: Please see Supplementary References for references to these assays