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.
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Oncotype DX, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Translational research: crossing the valley of death, The valley of death between lab and product.
Shares Translational research: crossing the valley of death, The valley of death between lab and product.
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares AI quantification of HER2-low and HER2-ultralow, Digital pathology & AI, Biomarkers are not validated or standardised.