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

Source: https://onco.cc/ideas/idea-moon-biomarker-validation-utility/  
OnCo record `idea-moon-biomarker-validation-utility` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed test: 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
- Actor: data

## Sources

- Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022): https://doi.org/10.1001/jamaoncol.2021.7239

## Connected records

- technologies: [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Proteomics & phosphoproteomics](https://onco.cc/technologies/proteomics/)
- institutions: [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/), [Preclinical results do not reproduce](https://onco.cc/bottlenecks/b-reproducibility/)
- key papers: [Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue](https://onco.cc/key-papers/paper-fernandez-jama-oncol/)

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