ideasIdea
Hold organoid drug tests to the same standard as a diagnostic test
Lab-grown mini-tumours are already being sold to guide treatment, but the tests are not validated like other medical tests. They should be.
Functional drug-response assays are entering clinical use without the analytical validation (precision, repeatability, reference ranges, failure rate reporting) or clinical validation (prospective outcome correlation) required of companion diagnostics. The proposal is a formal assay validation framework, developed with regulators, defining minimum performance, standardised reporting of derivation success rate, and mandatory registry submission of predictions and outcomes.
Hypothesis
Applying a diagnostic-grade validation framework reveals substantial inter-laboratory variability in organoid drug-response calls, and standardisation improves concordance and predictive value.
Rationale
Similar frameworks converted next-generation sequencing panels from research assays into reimbursed diagnostics; the absence of one is why functional testing is still viewed sceptically.
What would test it
Ring trial in which five laboratories test identical samples with their own protocols; measure concordance and then repeat after adopting a common protocol.
Maturity
preclinical evidence
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
3
Bottlenecks it attacks
- Preclinical models that do not predict people · Nine in ten cancer drugs that work in mice fail in humans. Our models are the reason.
- 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.
- Preclinical results do not reproduce · Fewer than half of landmark cancer biology findings reproduce when someone else tries.