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Table 1 Why well-validated biomarkers still fail to reach the clinic?

From: The failure of protein cancer biomarkers to reach the clinic: why, and what can be done to address the problem?

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
  1. CA: carbohydrate antigen; PSA: prostate-specific antigen