Table 1.

Overview on omics-driven commercially available biomarker-based tests.

Biomarker Test	Omics Features	Assay Method	Biofluid/Biospecimen	Clinical Application	References
STHLM3 nomogram	PSA, free PSA, intact PSA, KLK2, MSMB, MIC1, 232 SNPs, age, family, history, DRE SNPs	PSA immunoassays + SNP genotyping	Serum	Diagnostic Guiding 1st biopsy	Grönberg et al., 2015 [68]
Select MDx	HOXC6 and DLX1 mRNAs	RT-PCR	Urine-based (post-DRE)	Diagnostic Guiding 1st biopsy	Van Neste et al., 2016 [32]
ExoDx Intelliscore	PCA3, ERG and SPDEF Exosomal mRNAs	RT-PCR	Urine	Diagnostic Guiding 1st biopsy	McKiernan et al., 2018 [34]
Progensa CA3	PCA3 (DD3) lnc RNA	RT-PCR	Urine (post-DRE)	Diagnostic Guiding 1st biopsy & repeated biopsies	Hessels et al., 2003 [31]; Marks et al., 2007 [29]; Ramos et al., 2013 [30]
MiProstate	TMPRSS2-ERG and PCA3 Gene fusion & lnc RNA	RT-PCR	Urine (post-DRE)	Diagnostic Guiding 1st & repeated biopsies	Leyten et al., 2014 [69] Tomlins et al., 2016 [33]
Confirm MDx	GSTP1, APC, RASSF Methylation	Multiplex PCR	Tissue (Biopsy)	Diagnostic Guiding repeated biopsies	Partin et al., 2014 [35]
OncotypeDx	12 cancer-related genes (AZGP1, KLK2, SRD5A2, FAM13C, FLNC, GSN, TPM2, GSTM2, TPX2, BGN, COL1A1, SFRP4) and 5 reference genes mRNAs	RT-PCR	Tissue (Biopsy)	Diagnostic Guiding repeated biopsies Prognostic Guiding active treatment & AS	Klein et al., 2014 [46] Cullen et al., 2015 [47]
SChLAP1	SChLAP1 lnc RNA	Microarray hybridization	Tissue (Radical prostatectomy)	Prognostic Guiding active treatment & AS	Prensner et al., 2015 [56]
Decipher	22 coding and non-protein coding regions mRNAs	Affymetrix microarrays	Tissue	Prognostic Monitoring metastasis	Glass et al., 2016 [42] Ross et al., 2014 [43]
Prolaris	31 cell cycle progression and 15 reference genes mRNAs	RT-PCR	Tissue (Radical prostatectomy)	Prognostic Monitoring biochemical recurrence	Leon et al., 2018 [50]
AR-V7	AR-V7 CTCs	RT-PCR, ddPCR	Serum	Predictive Response to abiraterone/enzalutamide	Seitz et al., 2017 [70,71,72,73]
DNA repair genes	BRCA1, BRCA2, or ATM mRNAs	Next-Generation Sequencing	Tissue	Predictive Response to opaparib	de Bono et al., 2020 [67]

Table Abbreviations: ATM—ataxia telangiectasia-mutated gene, APC—adenomatous polyposis coli, AR-V7—androgen-receptor splice variant 7 messenger RNA, AZGP1—zinc α 2-glycoprotein, BGN—biglycan, BRCA1—breast cancer type 1 susceptibility protein, BRCA2—breast cancer type 2 susceptibility protein, COL1A1—collagen alpha-1(I) chain, ddPCR—droplet digital PCR, DLX1—homeobox protein DLX-1, DRE—digital rectal examination, ERG—transcriptional regulator ERG, FAM13C—protein FAM13C, FLNC—filamin-C, GSN—gelsolin, GSTM2—glutathione S-transferase Mu 2, GSTP1—glutathione S-transferase pi gene, HOXC6—homeobox protein Hox-C6, KLK2—kallikrein-2, MIC1—macrophage inhibitory cytokine 1, MSMB—microseminoprotein beta, PCA3—prostate cancer gene 3, PSA—prostate specific antigen, RASSF—Ras association domain-containing protein 1, RT-PCR—reverse transcription polymerase chain reaction, SChLAP1—second chromosome locus associated with prostate-1, SFRP4—secreted frizzled-related protein 4, SNPs—single nucleotide polymorphisms, SPDEF—SAM pointed domain-containing Ets transcription factor, SRD5A2—steroid 5 Alpha-Reductase 2, TMPRSS2—transmembrane serine protease 2, TPM2—tropomyosin beta chain, TPX2—targeting protein for Xklp2.