APPLICATION

Predicting Gastrointestinal Toxicity

GI toxicity is a leading cause of clinical adverse events, yet most preclinical models consistently fail to flag it. The MIMETAS OrganoReady® Colon Organoid gives you a human-relevant readout you can act on — as a ready-to-use plate you run yourself, or as a fully outsourced and standardized OrganoServices study.

28
clinically diarrheagenic and non-diarrheagenic compounds validated
79%
sensitivity for GI tox prediction
92%
specificity for GI tox prediction
THE CHALLENGE

Conventional Models
Fall Short

Animal studies and standard 2D cell lines don’t replicate the polarized, perfused epithelium of the human gut. The result: GI liabilities that pass preclinical screening only to surface in Phase I or later.

Conventional models
Animal models
Poor translational concordance. Species difference limit predictivity.
Caco-2 monolayers
Limited physiological relevance. No flow, no mucus, low diversity.
Static cultures
Lack of shear stress and flow. Does not reflect in vivo conditions.
Single endpoint readouts
Often rely on one parameter. Limited insight into complex toxicity.
Low late-stage predictivity
Many compounds fail in clinical trials due to poor early predictions.
MODEL FEATURES

Predicting GI Tox with the OrganoReady® Colon Organoid

Human stem cell-derived, perfused: a polarized tubular epithelium with intact transport, metabolism, and barrier function.

OrganoReady® Colon Organoid
Adult stem cell-derived
primary human colon tissue
Human colon organoid epithelium at high magnification
Perfused under flow
physiological shear stress maintained
OrganoPlate chips perfused under gravity-driven flow
Polarized epithelium
apical-basolateral polarity preserved
Side view of a perfused colon organoid tubule
Dual endpoint readout
TEER + ATP luminescence, day 2 & day 5
TEER
ATP
Dose-response structured
6 concentrations, 3 replicates
Dose-response curves for a reference compound

Tested Against
Clinical Outcomes

A retrospective study with 28 reference compounds — 14 clinically characterized GI-toxic and 14 non-toxic drugs — characterized the model’s predictive performance against the gold-standard Caco-2 Transwell assay (TEER & ATP).

OrganoReady Colon Organoid
Sensitivity
78%
(7/9 GI tox drugs)
Specificity
92%
(11/12 non-GI tox drugs)
Caco-2 Transwells (TEER & ATP)
Sensitivity
56%
(5/9 GI tox drugs)
Specificity
92%
(11/12 non-GI tox drugs)
Dose-response curves for viability and barrier integrity

Callout: colchicine was flagged at submicromolar concentrations, consistent with its clinical GI toxicity profile — representative of the 28-compound reference panel.

HOW TO WORK WITH US

Three Ways to
Get Started

Whether you want to run it yourself, hand it to us, or design something custom — we’ve got you covered.

PRODUCT
OrganoReady® Colon Organoid
Ready-to-use organoid kits for in-house GI tox assays on the OrganoPlate®. Full protocols included.
SERVICES
OrganoServices GI Tox
We run the validated assay for you. Results report within one week of assay completion. Your IP, exclusively.
SERVICES
Custom Services
Need a modified protocol, additional endpoints, or a disease-specific model? We design the study with you.
Not sure which option fits your program? Talk to a scientist — no sales pitch, just a conversation about your compound and timeline.
FROM THE FIELD

What Our Customers Say

At Bayer, we’ve integrated the OrganoReady® Colon Organoid Model with the OrganoTEER® system into our routine toxicity screening, because it delivers more physiologically relevant and reproducible data than conventional intestinal models. Using Afatinib as a positive control, we consistently see stable IC₅₀ values, confirming the reliability of the model and the precision of the OrganoTEER® readout.

Marian Raschke
Senior Scientific Director - Advanced Cellular Models

We used the OrganoReady® Colon Organoid to assess potential human gastrointestinal toxicity, and even as a first-time user the workflow was straightforward from receipt to data acquisition. Positive controls performed as expected, and the data quality supported interpretation of mechanisms and relative compound effects. Reproducibility across plates was strong, and with plate-level design we minimized variability and obtained the needed insights with a small sample size.

Takuya Kondo
Senior Researcher – Preclinical Basic Research, TAIHO Pharmaceutical
ADDITIONAL RESOURCES

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App note
Ready-to-use organoid kits for in-house GI tox assays on the OrganoPlate®. Full protocols included.
App note
Revolutionizing Intestinal Toxicity with Perfusable Adult Stem Cell-Derived Organoids.
OrganoReady Blood Vessel HUVEC / Caco-2
Need a modified protocol, additional endpoints, or a disease-specific model? We design the study with you.

Interested? Got a Question?

Reach out to us — we’ll help you find the right way to get your GI toxicity data.