{"entity":{"id":"idea-moon-biomarker-validation-utility","kind":"idea","name":"A public biomarker validation utility with pre-diagnostic biobanks and blinded testing","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2021.7239"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["liquid-biopsy","proteomics"],"targets":[],"drugs":[],"companies":[],"institutions":["nci"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-biomarker-validation","b-reproducibility"],"keyPapers":["paper-fernandez-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"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.","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","cost":"large","horizonYears":5},"route":"/ideas/idea-moon-biomarker-validation-utility/","neighbours":{"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"proteomics","kind":"technology","name":"Proteomics & phosphoproteomics","route":"/technologies/proteomics/"}],"institution":[{"id":"nci","kind":"institution","name":"National Cancer Institute (NIH)","route":"/institutions/nci/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-reproducibility","kind":"bottleneck","name":"Preclinical results do not reproduce","route":"/bottlenecks/b-reproducibility/"}],"paper":[{"id":"paper-fernandez-jama-oncol","kind":"paper","name":"Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue","route":"/key-papers/paper-fernandez-jama-oncol/"}]}}