Table 1

Why well-validated biomarkers still fail to reach the clinic?

Clinical application

Reason to Fail


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


• 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


• 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

Diamandis BMC Medicine 2012 10:87   doi:10.1186/1741-7015-10-87

Open Data