{"entity":{"id":"idea-bio1-organoid-assay-clinical-validation","kind":"idea","name":"Hold organoid drug tests to the same standard as a diagnostic test","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Lab models that fail to predict what happens in patients): Wong, Siah & Lo, Estimation of clinical trial success rates (Biostatistics 2019)","url":"https://doi.org/10.1093/biostatistics/kxx069"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["functional-drug-testing","organoids","companion-diagnostic"],"targets":[],"drugs":[],"companies":["sengine","xilis","curesponse"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-preclinical-models","b-biomarker-validation","b-reproducibility"],"keyPapers":["paper-wong-biostatistics"],"journals":[],"dependsOn":[],"notes":[],"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.","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","cost":"small","horizonYears":3},"route":"/ideas/idea-bio1-organoid-assay-clinical-validation/","neighbours":{"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"functional-precision-medicine-haematology","kind":"technology","name":"Ex vivo drug sensitivity screening in blood cancers (EXALT)","route":"/technologies/functional-precision-medicine-haematology/"},{"id":"functional-drug-testing","kind":"technology","name":"Functional (ex vivo) drug testing","route":"/technologies/functional-drug-testing/"},{"id":"organoids","kind":"technology","name":"Patient-derived organoids","route":"/technologies/organoids/"}],"company":[{"id":"curesponse","kind":"company","name":"Curesponse","route":"/companies/curesponse/"},{"id":"sengine","kind":"company","name":"SEngine Precision Medicine","route":"/companies/sengine/"},{"id":"xilis","kind":"company","name":"Xilis","route":"/companies/xilis/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-preclinical-models","kind":"bottleneck","name":"Lab models that fail to predict what happens in patients","route":"/bottlenecks/b-preclinical-models/"},{"id":"b-reproducibility","kind":"bottleneck","name":"Preclinical results do not reproduce","route":"/bottlenecks/b-reproducibility/"}],"paper":[{"id":"paper-wong-biostatistics","kind":"paper","name":"Estimation of clinical trial success rates and related parameters","route":"/key-papers/paper-wong-biostatistics/"}]}}