Table 2 Clinically significant different biomarkers for the diagnosis of PC
From: Recent advances and future perspectives in the therapeutics of prostate cancer
Test | Company | Biomaterial | Biomarker details | Clinical utility | Test outcome | Certification | References |
|---|---|---|---|---|---|---|---|
PHI | Beckman Coulter Inc | Blood serum | Free PSA (fPSA), total PSA (tPSA), and [-2] proPSA | Initial biopsy and rebiopsy | Differentiates benign conditions and malignant prostate cancers Decreases unnecessary biopsies | US FDA | [68] |
4K score | OPKO Health Inc | Blood plasma | Free PSA (fPSA), total PSA (tPSA), intact PSA (iPSA), and human kallikrein 2 (hK2) | Initial biopsy and rebiopsy | Differentiates high-grade and indolent prostate cancer Decreases unnecessary biopsies | CLIA | [69] |
PCA3 | Hologic Inc | Post DRE urine | PSA mRNA, lncRNA PCA3 | Rebiopsy | Decreases unnecessary biopsies | US FDA | [70] |
Exo-Dx | Exosome Diagnostics | Urine | Exosomal mRNA (PCA3, ERG, and SPDEF) | Initial biopsy and rebiopsy | Differentiates high-grade and indolent prostate cancer Decreases unnecessary biopsies | CLIA | [71] |
SelectMDx | MDxHealth | Post DRE first void urine | DLX1, KLK3, HOXC6, mRNA and PSA | Initial biopsy and rebiopsy | Differentiates high-grade and indolent prostate cancer. Decreases unnecessary biopsies | CLIA | [72] |
TMPRSS2-ERG | Blood tissue and urine | Post DRE urine | Fusion gene TMPRSS2-ERG | Initial biopsy | Differentiates high-grade and indolent prostate cancer Decreases unnecessary biopsies | No | [73] |
Mi-Prostate Score | Michigan Labs | Post DRE first void urine | PCA3 and TMPRSS2-ERG mRNA, tPSA | Initial biopsy | Differentiates high-grade and indolent prostate cancer Decreases unnecessary biopsies | CLIA | [74] |
ConfirmMDx | MDx Health | Tissue | Hypermethylation of genes- GSTP1, APC and RASSF1, PSA | Rebiopsy | Decreases unnecessary biopsies | CLIA | [75] |