12/08/2026
Science Wednesdays: Validation vs Verification
A biomarker is a measurable signal in the body (e.g., a protein in the blood) that tells us something meaningful about a disease. Finding reliable biomarkers for ME/CFS is a critical need in the field, but before any biomarker can be used to diagnose patients or guide treatment, it has to pass two critical tests: verification and validation.
Verification: "Can we reliably detect it?"
Verification confirms that a biomarker can be measured consistently and accurately. It answers the question: if this signal is present, can our tools detect it reliably—every time, across different labs, different equipment, and different operators? A biomarker that shows up clearly in one lab but disappears in another hasn't been verified.
Validation: "Does it actually mean what we think it means?"
Validation takes a step beyond verification, trying to confirm that a biomarker genuinely reflects the biology of the disease—it’s not a coincidence, not a side effect of medication, not a pattern that appears in healthy people, too. Validation asks: does this signal hold up across different patient groups, different disease stages, and different research settings? A validated biomarker is critical for eventual use in a clinical setting.
Why does verification and validation matter for ME/CFS?
ME/CFS research has historically suffered from findings that generated excitement but couldn't be reproduced—results that appeared in one study but failed to hold up elsewhere. This is not unique to ME/CFS, but unverified or unvalidated findings stall progress, erode trust, and delay the development of real diagnostic tools that are desperately needed by hundreds of millions of people around the world. Rigorous verification and validation are how researchers ensure that a promising signal becomes a proven one and that patients ultimately benefit from discoveries.
Putting this into practice, the plans for OMF’s large-scale biomarker project, BioQuest, account for verification and validation of any signal identified in the discovery phase. BioQuest’s phase 2 will verify the biomarker signature in an independent cohort, determining if the results are reproducible on new data. Then, a prospective study will be conducted to validate that reproducible signature and address clinical utility. Read more about the first phase of the BioQuest study on our website: https://www.omf.ngo/bioquest-large-scale-biomarker-project/