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.
Pages like this
not linked directly; found by shared links- IdeaA reliance pathway for companion diagnostics so the test arrives with the drug
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaDrug labels must state which biomarker assays were validated and how they compare
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaRegulators recognise each other's companion diagnostic approvals
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaA formal regulatory route for validating a biomarker on archived trial samples
Shares Oncotype DX, Companion diagnostic, Biomarkers are not validated or standardised.
- IdeaA breath test to rule out cancer in people with vague symptoms
Shares Positive predictive value (PPV), Biomarkers are not validated or standardised.
- IdeaTest the drug in biomarker-negative patients too, so the biomarker can be validated
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaVersion control and locked reference sets for AI algorithms used as companion diagnostics
Shares AI quantification of HER2-low and HER2-ultralow, Digital pathology & AI, Biomarkers are not validated or standardised.
- IdeaCalibrated reference slides so every lab scores HER2-low the same way
Shares AI quantification of HER2-low and HER2-ultralow, Digital pathology & AI, Biomarkers are not validated or standardised.