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.

OrganoReady® Colon Organoid in numbers

28
clinically diarrheagenic and non-diarrheagenic compounds validated
79%
sensitivity for GI tox prediction
93%
specificity for GI tox prediction
A retrospective study on OrganoReady® Colon Organoid
THE CHALLENGE

Conventional Models Fall Short,
OrganoReady® Revolutionize GI Tox Predictions

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. The OrganoReady® Colon Organoid replicates the gut physiology, giving you predictions that correlate with real clinical outcomes so you can de-risk and prioritize compounds with confidence. Because it can be dosed apically and basolaterally independently, you can test oral and systemic exposure in the same model, without switching assays.

Conventional Model
Poor translational concordance, species differences limit predictivity.
Limited physiological relevance, no mucus, low diversity.
Low late-stage predictivity — many compounds fail in clinical trials due to poor early predictions.
OrganoReady® Colon Organoid
Organoid derived from primary human colon tissue
Derived from primary human colon tissue for direct translatability to patients.
Multiple cell types including mucus-producing cells
Recapitulates multiple cell types present in vivo that are important for functional screenings.
Dose-response curve validated against clinical outcomes
Proven predictivity based on validation against real clinical outcomes.

Validated Platform,
Move with Confidence into Your Next Development Stage

GI liabilities missed by rodents and traditional cell lines surface when stakes are high: close to, or during clinical trials. In a head-to-head against Caco-2 in Transwell®, the OrganoReady® Colon Organoid performed better with 78% sensitivity versus 56% sensitivity for Caco-2, both at 92% specificity. Taken together, the OrganoReady® Colon Organoid yields a more defensible basis for advancing or deprioritizing compounds earlier in the program.

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
A retrospective study with 28 reference compounds, 14 clinically characterized GI-toxic and 14 non-toxic drugs, characterized the model's predictive performance at 79% sensitivity and 93% specificity. In a head-to-head comparison with the gold-standard Caco-2 Transwell assay, the OrganoReady Colon Organoid outperformed with 78% sensitivity versus 56% in Caco-2 with equal specificity (92%). (Peters, 2018)

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
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
“

The OrganoPlate® 3-lane platform with the OrganoTEER® will become a standardized assay in our early investigative toxicology drug screening workflow. With the OrganoPlate® we see a reproducible early screen for intestinal toxicity, and the first example internally of an advanced cell model being implemented into routine testing. To date, the OrganoReady® Caco-2 model is for us, at Merck, the most suitable platform offering at the same time scalability, speed, robustness, ease of handling, with low compound needs.

Philip Hewitt
Early Investigative Toxicology, Pre-clinical Safety, Merck

Ready to Get Started?

Ship your compound and get a structured, human-relevant results report — typically within a week of assay completion.