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 |