Table 1.
Why well-validated biomarkers still fail to reach the clinic?
| Clinical application | Reason to Fail | Example |
|---|---|---|
| Population screening and diagnosis | • screening does not save lives; overdiagnosis/overtreatment | PSA and prostate cancer screening |
| • too many false positives leading to unnecessary and invasive confirmatory procedures | • CA 125 for ovarian cancer screening | |
| • marker not profitable if marketed | • B7-H4 for ovarian cancer diagnosis | |
| Prognosis | • weak prognostic value; clinicians prefer to overtreat instead of undertreat | • p53 and uPA/PAI1 for breast cancer |
| • no effective therapy available | • CA 19.9 for pancreatic cancer | |
| Monitoring | • no therapy for relapsing disease | • CA125 for detection of early relapse of ovarian cancer |
| Evaluating therapeutic response | • many false positives and false negatives | • CA 15.3 for breast cancer |
CA: carbohydrate antigen; PSA: prostate-specific antigen