Regulatory explainer
A biomarker needs a clearly defined job
FDA distinguishes biomarker categories and explains qualification within a stated context of use. A biomarker can be a molecular, tissue, imaging or physiological measurement.
Human observational study
What a proteomic aging clock can tell us
Nature Medicine · Aug 8, 2024
What the source reports
A 204-protein clock, developed using 45,441 UK Biobank participants, was associated with future disease and mortality risk and evaluated in Chinese and Finnish cohorts.
Why it belongs here
Circulating proteins may help characterize risk and biological differences that chronological age alone misses.
WHAT THIS DOES NOT ESTABLISH
Risk prediction does not establish that changing this clock with a treatment improves health or extends life.
Before you use it
Read the original source, check its population or model and intended use, and review uncertainty, disclosures and any subsequent updates. This note is a guide to reading, not a substitute for the paper or guidance.
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Regulatory explainer
A promising signal is not the same as a proven benefit
FDA explains why surrogate endpoints require careful evaluation: a biomarker may not capture a treatment’s full benefits and risks.