Table 1.

EDRN prostate collaborative group biomarker development achievements.

BiomarkerEDRN roleClinical utilityOutcome/Status
PHI (17)ValidationEarly detection prior to initial biopsyFDA-approved
ProPSA (20)ValidationEarly detection prior to initial biopsyFDA-approved
TMPRSS2:ERG fusion (T2:ERG; ref. 28)Discovery, validationEarly detection prior to initial or repeat biopsyCLIA-complianta/commercially deployed
Urine PCA3, T2:ERG (e.g., MIPs; ref. 75)ValidationEarly detection prior to initial or repeat biopsyFDA-approved (PCA3); CLIA (T2:ERG)
Tissue/urine RNA-seq (76)Discovery to clin assayEarly detection biomarker developmentCLIA-compliant
MiCheck (77)ValidationEarly detection prior to initial or repeat biopsyCLIA-compliant
Mitochondrial deletion (78)Discovery, validationEarly detection biomarker development (biopsy)CLIA-compliant
Decipher (SChLAP1; ref. 79)Discovery, validationSalvage radiotherapy after prostatectomyCLIA-compliant
GSTP1 (80)ValidationEarly detection biomarker development (prostatectomy)CLIA-compliant
Urine transcriptome (32)Discovery to clin assayEarly detection biomarker developmentCLIA-compliant
Flucyclovine PET (81)ValidationPreoperative stagingExpanded indication
  • aThe assay/test performance meets CLIA guidelines.