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Table 2 Newly emerging tests for prostate cancer

From: Clinical proteomics for prostate cancer: understanding prostate cancer pathology and protein biomarkers for improved disease management

Assay Marker description Assay type Biomaterial FDA approved
Tissue-based
Oncotype DX 17 genes RT-PCR FFPE needle core biopsy No
Prolaris 46 genes RNA expression FFPE needle core biopsy Yes
ProMark 8 proteins Immnofluorescent imaging FFPE needle core biopsy No
Decipher 22 coding and non-coding RNAs Whole-transcriptome microarray FFPE needle core biopsy No
Confirm MDx 3 genes Quantitative methylation-specific PCR Prostate needle core biopsy No
PCMT mtDNA deletions Quantitative PCR (specific for mtDNA) Prostate needle core biopsy No
Fluid-based
phi PSA, fPSA, p2PSA Multi-analyte Immunoassay Serum Men > 50 with total PSA 4–10 ng/mL and negative DRE
4K score Total PSA, fPSA, intact PSA, hK2 Multi-analyte Immunoassay Plasma No
Progensa (PCA3) PSA and PCA3 mRNA In vitro RNA TMA assay Post-DRE first void urine Only when repeat biopsy considered
SelectMDx HOXC6, DLX1, KLK3 Reverse transcription PCR (RT-PCR) Post-DRE first void urine No
MiPS PSA,PCA3 and TMPRSS2:ERG mRNAs In vitro RNA TMA and Hybrid Protection Assay (HPA) Post-DRE first void urine No
Prostarix 4 Amino acids: sarcosine, alanine, glycine and glutamate Liquid chromatography and mass spectrometry Post-DRE urine No
ExoDx prostate (IntelliScore) Exosomal RNA (ERG, PCA3, SPDEF) RT-PCR Urine No
  1. Table adapted from Falzarano et al. [141]