A fund for prospective validation of academic biomarkers and companion diagnostics
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.
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.
- The valley of death between lab and product · Most academic discoveries die before anyone tests them in people because nobody funds the middle step.
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.