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.
- 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.
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not linked directly; found by shared links- IdeaTest drugs on the patient's own cancer cells when there is no trial to join
Shares Curesponse, SEngine Precision Medicine, Xilis, Functional (ex vivo) drug testing.
- IdeaGrow each trial patient's tumour as organoids to decide which platform arm opens next
Shares Curesponse, SEngine Precision Medicine, Xilis, Functional (ex vivo) drug testing.
- TechnologyOrganoid-guided therapy at scale
Shares Curesponse, SEngine Precision Medicine, Xilis, Functional (ex vivo) drug testing.
- IdeaTest drugs on freshly cut slices of the patient's own tumour
Shares Curesponse, Functional (ex vivo) drug testing, Patient-derived organoids, Preclinical models that do not predict people.
- IdeaRun the mouse or organoid trial at the same time as the human trial
Shares Xilis, Functional (ex vivo) drug testing, Patient-derived organoids, Preclinical models that do not predict people.
- IdeaA bone marrow niche on a chip to study human dormancy
Shares Functional (ex vivo) drug testing, Patient-derived organoids, Preclinical models that do not predict people.
- InstitutionAtrium Health Wake Forest Baptist Comprehensive Cancer Center
Shares Functional (ex vivo) drug testing, Patient-derived organoids, Preclinical models that do not predict people.
- IdeaScore every model system on how well it predicted real trial results
Shares Patient-derived organoids, Preclinical results do not reproduce, Preclinical models that do not predict people.