The three evidence layers
- • Analytical validity — the test accurately and reliably measures what it claims to measure.
- • Clinical validity — the result correlates with the clinical condition or outcome of interest.
- • Clinical utility — using the result changes management in a way that benefits patients or the health system.
Why clearance evidence is rarely enough
Regulatory submissions typically focus on analytical and clinical validity. Coverage decisions frequently turn on clinical utility, which requires evidence that ordering the test leads to different, better decisions.
Designing utility studies with payers in mind
- • Define the specific management decision the test is meant to change.
- • Choose endpoints payers value: avoided procedures, time to correct therapy, downstream cost.
- • Consider decision-impact studies and real-world evidence alongside prospective trials.
- • Engage payer and guideline perspectives before finalizing study design.
Timing the evidence plan
The strongest programs map evidence generation onto the commercial timeline: what is needed for initial coverage, what is needed for guideline inclusion, and what will sustain broad adoption.
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