Table 2 Newly emerging tests for prostate cancer
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 |