OnCo
ideasIdea

A public biomarker validation utility with pre-diagnostic biobanks and blinded testing

Thousands of cancer biomarkers are published; almost none reach patients because nobody validates them fairly. Create a public service that tests any candidate blind against stored samples.

Biomarker failure stems from small discovery sets, spectrum bias and absence of blinded validation on prospectively collected samples. Cohorts with pre-diagnostic samples (UK Biobank, PLCO, national screening biobanks) and trial biorepositories exist but access is slow and fragmented. The proposal is a funded utility: a governed catalogue of pre-diagnostic and trial samples with outcomes, a standard blinded validation protocol (PRoBE design), rapid access for academic and commercial developers at cost, and public reporting of all results including failures.

Hypothesis
The utility validates or refutes at least 100 candidate biomarkers in five years, and biomarkers passing it show performance in clinical use within a third of the historical time and with markedly less performance decay.
Rationale
Early Detection Research Network experience shows blinded validation kills most candidates quickly and cheaply; a shared utility makes that the default rather than the exception.
What would test it
Fund the utility and run the first 20 blinded validations; measure throughput, time to result, and concordance of validated performance with later clinical performance.
Maturity
early clinical
Who has to act
data
Cost to try
Large (over $50M)
Years to first evidence
5
Bottlenecks it attacks

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