Table 2.
Emerging PCa biomarkers commercially available
| Panel | Manufacturer | Specimen | Description | Clinical usefulness | Approved by FDA |
|---|---|---|---|---|---|
| PHI13,14 | Beckman Coulter |
Serum | Measures total PSA, fPSA, and p2PSA | PCa detection and prognosis | Yes |
| Four-kallikrein panel (4Kscore)19 | Opko | Serum or plasma | Measures total PSA, fPSA, iPSA, and hK2 | PCa detection and prognosis | No* |
| PCA332 | Hologic | Urine collected after prostate massage | Measures mRNA PCA3 in relation to mRNA PSA | PCa detection. Contradictory results concerning prognosis | Yes |
| Circulating tumor cells (CellSearch® platform)66 | Janssen Diagnostics |
Whole blood | Measures circulating tumor cells on CellSearch platform | Associated with decreased overall survival in metastatic PCa | Yes |
| OncotypeDX® AR-V7 Nucleus Detect75,77 |
Epic Sciences | Whole blood | Measures expression of AR-V7 in the nucleus of circulating tumor cells | To select treatment for CRPC patients | No* |
Note:
*
These biomarkers are available from CLIA-certified clinical laboratories.
Abbreviations: AR-V7, androgen receptor splice variant-7; CLIA, Clinical Laboratory Improvement Amendment; CRPC, castration-resistant PCa; FDA, US Food and Drug Administration; fPSA, free PSA; hK2, human kallikrein 2; iPSA, intact PSA; PCa, prostate cancer; PCA3, prostate cancer gene 3; PHI, Prostate Health Index; PSA, prostate-specific antigen.