Table 1.

Prostate cancer diagnostic and prognostic biomarkers.

Test	Company	Sample Input	Testing Platform	Outcome	References
Clinically available biomarkers for diagnostic assessment
ExoDx®	Exosome Diagnostics	Urine	Transcript quantification of PCA3 and TMPRSS2:ERG	Initial biopsy	[38,39]
Mi-Prostate Score	University of Michigan	Post-DRE urine	Transcript quantification of PCA3 and TMPRSS2:ERG, in combination with PSA level	Initial biopsy	[82,83]
SelectMDx	MDxHealth	Post-DRE urine	Transcript quantification of DLX1 and HOXC6	Initial biopsy	[63]
Progensa PCA3	Hologic	Post-DRE urine	Transcript quantification of PCA3 and PSA	Rebiopsy	[60,61]
4Kscore®	OPKO Diagnostics	Blood	Immunoassay panel for tPSA, fPSA, iPSA, and hK2	Rebiopsy	[64,84,85,86]
ConfirmMDx	MDxHealth	Prostate tissue	PCR-based determination of the methylation status of GSTP1, APC, and RASSF1	Rebiopsy	[66,67,87,88]
Prostate Health Index	Beckman Coulter	Blood	Immunoassay panel for tPSA, fPSA, and p2PSA	Initial biopsy/rebiopsy	[65,89,90]
Molecular panels for prognosis and risk stratification
NaDiA® ProsVueTM	Beckman Coulter	Blood	Total serum PSA	Management post-RP	[70,71]
DecipherTM	GenomeDx Biosciences	RP	Transcriptomic microarray profiling of 22 gene markers	Management post-RP	[75,91]
Oncotype DX®	Genomic Health	Prostate tissue	Quantitative PCR for 12 PCa-related genes and 5 housekeeping controls	Active surveillance or treatment initiation	[76,77]
Prolaris®	Myriad Genetics	Prostate tissue	Quantitative PCR for 31 cell cycle-related genes and 15 housekeeping controls	Active surveillance or treatment initiation	[78,79]
ProMark®	Metamark	Prostate tissue	In situ measurement of 8 protein biomarkers by automated image analysis	Active surveillance or treatment initiation	[80,81,92]

PSA = prostate-specific antigen; tPSA = total PSA; fPSA = free PSA; p2PSA = [−2]proPSA; DRE = digital rectal examination; RP = radical prostatectomy.