# A fund for prospective validation of academic biomarkers and companion diagnostics

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

## TL;DR

Thousands of tests that could predict who benefits from a treatment are published and never validated. A fund would pay for the boring but essential confirmation studies in independent patient groups.

## Summary

A fund that pays for locked-down assay development, analytical validation and prospective or prospective-retrospective clinical validation of academic biomarkers with strong signals (predictive signatures, ctDNA thresholds, imaging or pathology AI scores), using banked samples from completed randomised trials under standard access agreements and independent statistical analysis. Diagnostics are far less profitable than drugs, so companies rarely take on validation of academic markers, and academic groups lack money for the multi-centre studies regulators and guidelines require. Prioritisation favours biomarkers that would spare patients ineffective treatment or de-escalate therapy.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: A biomarker validation fund of $30 million a year moves at least ten academic biomarkers per five years to guideline-endorsed or regulator-recognised status, compared with very few today, with at least three leading to treatment de-escalation or avoidance in practice.
- Rationale: The tests that changed practice (Oncotype DX, MammaPrint, MSI, PD-L1 in specific contexts) all required prospective-retrospective validation on trial cohorts; the NCI's Biomarker, Imaging and Quality of Life Studies Funding Program and EORTC's SPECTA show the path exists but is small. Access to trial samples and independent analysis are the bottlenecks money can fix.
- Proposed test: Fund validation of five biomarkers on banked randomised-trial samples and compare time to guideline consideration and regulatory recognition with matched unfunded biomarkers.
- Maturity: speculative
- Actor: philanthropy

## Sources

- Bottleneck evidence (The valley of death between lab and product): Butler, Translational research: crossing the valley of death (Nature 2008): https://doi.org/10.1038/453840a

## Connected records

- ideas: [A commons for leftover trial biospecimens with standard access for approved research](https://onco.cc/ideas/idea-fund-trial-biospecimen-commons/), [AI quantification of HER2-low and HER2-ultralow](https://onco.cc/ideas/idea-ai-her2-low-scoring/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Digital pathology & AI](https://onco.cc/technologies/digital-pathology-ai/), [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/)
- drugs: [Oncotype DX](https://onco.cc/drugs/oncotype-dx/), [Signatera](https://onco.cc/drugs/signatera/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Positive predictive value (PPV)](https://onco.cc/terms/ppv/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/), [The valley of death between lab and product](https://onco.cc/bottlenecks/b-translational-valley/)
- key papers: [Translational research: crossing the valley of death](https://onco.cc/key-papers/paper-butler-nature/)

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