Table 1.
Summary of available tissue-based biomarkers and indications.
| Test Name | Manufacturer | Genetic Material tested | Endpoint | Test Report | Target Population | Reference |
|---|---|---|---|---|---|---|
| Repeat Biopsy | ||||||
| ConfirmMDx | MDxHealth | Methylation status of 3 genes (GSTP1, RASSF1, APC) |
Risk of PCa on repeat biopsy | Likelihood of PCa in % | Men with negative biopsy and considering second one | Stewart et al. (12), Partin et al. (13), Van Neste et al. (14) |
| After Biopsy: Active Surveillance vs. Intervention | ||||||
| Prolaris Biopsy | Myriad Genetics | Expression levels (RNA) of 31 cell-cycle progression genes | 10-year risk of PCa-specific mortality | CCP Score: 0-6 | Men with PCa on biopsy | Cuzick et al. (15, 16) |
| Decipher Biopsy | GenomeDx Biosciences | Expression levels (RNA) of 22 genes (LASP1, IQGAP3, NFIB, S1PR4, THBS2, ANO7, PCDH7, MYBPC1, EPPK1, TSBP, PBX1, NUSAP1, ZWILCH, UBE2C, CAMK2N1, RABGAP1, PCAT-32, GLYATL1P4, PCAT-80, TNFRSF19) |
5-year risk metastasis Likelihood of high grade PCa on RP 10-year risk of PCa-specific mortality |
GC Score: 0-1.0 | Men with localized PCa | Cooperberg et al. (17), Klein et al. (18), Ross et al. (19) |
| Oncotype DX | Genomic Health | Expression levels (RNA) of 12 genes (AZGP1, KLK2, SRD5A2, FAM13C, FLNC, GSN, TPM2, GSTM2, TPX2, BGN, COL1A1, SFRP4) |
Likelihood of GGG 1 or GGG2 on RP Likelihood of organ-confined PCa on RP |
GPS Score: 0-100 | Men with very low- and low- risk PCa* | Cullen et al. (20), Klein et al. (21) |
| ProMark | Metamark | Quantitative levels of 8 proteins (DERL1, CUL2, SMAD4, PDSS2, HSPA9, FUS, pS6, YBOX1) |
Risk of GGG ≥ 3 or non-organ confined PCa on RP |
ProMark Score: 0-100 | Men with GGG 1 or 2 on biopsy | Shipitsin et al. (22), Blume-Jensen et al. (23) |
| PTEN/ TMPRSS2:ERG |
Metamark | PTEN deletion and TMPRSS2:ERG fusion | Risk groups | Men with GGG 1 or 2 on biopsy | Yoshimoto et al. (24) | |
| Management after RP: Further Treatment vs. Observation | ||||||
| Prolaris | Myriad Genetics | Expression levels (RNA) of 31 cell-cycle progression genes | 10-year risk of BCR | CCP Score: 0-6 | Men after RP | Cuzick et al. (25), Cooperberg et al. (17) |
| Decipher | GenomeDx Biosciences | Expression levels (RNA) of 22 genes | 5-year risk of metastasis 10-year risk of PCa specific mortality |
GC Score: 0-1.0 | Men with high-risk pathology or high-risk clinical features after RP | Karnes et al. (26), Den et al. (27) |
PCa, prostate cancer; BCR, biochemical recurrence; CCP, cell cycle progression; GC, genomic classifier; GGG, Gleason grade group; GPS, genomic prostate score; RP, radical prostatectomy.
*based on NCCN risk group.