# Hold organoid drug tests to the same standard as a diagnostic test

Source: https://onco.cc/ideas/idea-bio1-organoid-assay-clinical-validation/  
OnCo record `idea-bio1-organoid-assay-clinical-validation` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Lab-grown mini-tumours are already being sold to guide treatment, but the tests are not validated like other medical tests. They should be.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed test: 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
- Actor: regulator

## Sources

- Bottleneck evidence (Lab models that fail to predict what happens in patients): Wong, Siah & Lo, Estimation of clinical trial success rates (Biostatistics 2019): https://doi.org/10.1093/biostatistics/kxx069

## Connected records

- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Ex vivo drug sensitivity screening in blood cancers (EXALT)](https://onco.cc/technologies/functional-precision-medicine-haematology/), [Functional (ex vivo) drug testing](https://onco.cc/technologies/functional-drug-testing/), [Patient-derived organoids](https://onco.cc/technologies/organoids/)
- companies: [Curesponse](https://onco.cc/companies/curesponse/), [SEngine Precision Medicine](https://onco.cc/companies/sengine/), [Xilis](https://onco.cc/companies/xilis/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/), [Lab models that fail to predict what happens in patients](https://onco.cc/bottlenecks/b-preclinical-models/), [Preclinical results do not reproduce](https://onco.cc/bottlenecks/b-reproducibility/)
- key papers: [Estimation of clinical trial success rates and related parameters](https://onco.cc/key-papers/paper-wong-biostatistics/)

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