Biomarker | Phase 1/2 | Phase 3 | Phase 4 | Phase 5/6 | Ready for clinical use? | Comments |
---|---|---|---|---|---|---|
LOH, loss of heterozygosity. | ||||||
Dysplasia | ✓ | ✓ | ✓ | X | Diagnostic but poorly prognostic | Ideally two or more specialist pathologists. Current gold standard but poor reproducibility; |
P53 | ✓ | ✓ | ✓ | X | No | Single phase 4 study showing 17p LOH is a good marker of progression |
P16 | ✓ | X | X | X | No | Hypothetically good but lacks scientific data |
Aneuploidy | ✓ | X | ✓ | X | No | Difficult technique to reproduce |
Cyclin D1 | ✓ | ✓ | X | X | No | Possible role in combination with p16 |
Ki-67 | ✓ | X | X | X | No | Single phase 4 trial found no evidence that S phase was a predictor of MCS progression |