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Intero Biosystems is developing GastroScreen, an iPSC-derived human intestinal organoid platform that drugmakers can use for toxicity, efficacy, inflammation, fibrosis and motility studies. The miniature intestines contain several interacting human cell types and produce functional readouts that flat cell cultures cannot provide.
GastroScreen is promising, but it is not yet a proven replacement for animal or clinical testing. Intero says its validation work is in the second of three stages, with direct comparisons against pharmaceutical animal and clinical data still underway.
What Intero Biosystems is building
Founded in 2024 as a University of Michigan spin-out, Intero Biosystems sells GastroScreen to pharmaceutical, biotechnology, food and chemical companies. It also runs custom studies and supplies the materials needed to culture and test the organoids.
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Outbyte Driver Updater FREEScan for outdated or missing drivers - takes under a minuteDriver Scan →Outbyte PC Repair FREEClear out junk files and repair common Windows errorsFree Scan →| Company detail | Reported information |
|---|---|
| Founded | 2024 |
| Origin | University of Michigan spin-out |
| Financing | $2.3 million pre-seed round, according to TechCrunch in 2026 |
| Team | Seven employees at the time of the 2026 TechCrunch report |
| Customers | Just under 10 customers at the time of that report |
| Revenue | More than $400,000 from the fourth quarter of the prior year through the third quarter of 2026, as reported by TechCrunch |
What GastroScreen contains
GastroScreen is designed as a miniature intestine rather than a single layer of cells. Intero says its iPSC-derived organoids include epithelial, mesenchymal, smooth-muscle, enteric-neuron and endothelial components. The company also reports spontaneous peristaltic-like contractions, perfusable vasculature and functional responses from the enteric nervous system.
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Customers can receive live or frozen vials containing more than 100 viable organoids. The material is intended to work with imaging, gene-expression, protein-expression, epithelial-barrier and other functional assays. That combination lets a study examine both molecular changes and tissue-level behavior.
How drugmakers can use the model
Toxicity and barrier safety
Researchers can test intestinal cytotoxicity, off-target toxicity and disruption of the epithelial barrier. These readouts are relevant when a candidate drug appears effective elsewhere but may injure the gut or alter its protective lining.
Gastrointestinal efficacy
For gastrointestinal medicines, studies can measure efficacy and target engagement in human intestinal tissue. Healthy organoids can be used as a baseline, while disease-like states can be induced for specific experiments.
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Inflammation and fibrosis
Intero lists inflammatory and fibrotic disease models among its applications. The company’s contract-study service can combine the organoids with custom experimental designs and data analysis.
Motility, vascular and neuromuscular measurements
Because the platform includes smooth muscle, enteric neurons, endothelial cells and perfusable vessels, customers can examine motility, vascular behavior and neuromuscular responses in addition to standard viability or gene-expression endpoints.
Can mini human intestines replace animal testing?
Not at this point. Intero’s chief executive, Charlie Childs, told TechCrunch that GastroScreen had produced expected responses to drugs known to reduce intestinal inflammation and to compounds known to damage the gut. Those results support the model’s biological plausibility, but they do not establish that it predicts every human outcome better than an animal model.
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Childs said the platform was in stage two of a three-stage validation process. The final stage is intended to compare GastroScreen results with pharmaceutical companies’ animal and clinical data, and TechCrunch reported that those studies were underway with several companies. Until those comparisons are completed and independently assessed, GastroScreen should be treated as a complementary preclinical method rather than a wholesale substitute.
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How GastroScreen differs from common alternatives
| Approach | Biological system | Functional information | Current qualification |
|---|---|---|---|
| GastroScreen | iPSC-derived human intestinal organoids with epithelial, mesenchymal, smooth-muscle, enteric-neuron and endothelial components | Barrier, molecular, vascular, motility and neuromuscular measurements; peristaltic-like contractions are reported by Intero | Validation is ongoing; animal and clinical comparisons have not been completed in the reported account |
| Flat cell monolayer | A simpler, usually single-layer cell culture | Useful for cell-level assays, but does not recreate the full multi-cell intestinal architecture described for GastroScreen | Less biologically complex than the organoid model |
| Animal model | Whole-animal physiology from a nonhuman species | Provides in-vivo measurements across organs, but responses may differ from human intestinal biology | Established as part of conventional preclinical research; GastroScreen’s replacement value remains to be demonstrated |
Patient-derived organoids and organ-on-chip systems are other approaches in the broader field. They may differ in how they represent patient variation, perfusion, throughput, manufacturing and assay automation. A fair comparison requires method-specific data rather than assuming that every organoid or chip has the same capabilities.
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What evidence and funding show
A peer-reviewed review places intestinal organoids within FDA-oriented New Approach Methodologies (NAMs) and describes their potential for more predictive intestinal-toxicity testing. It also stresses that regulatory use requires validation and appropriate evidence for the specific method and claim.
The National Center for Advancing Translational Sciences awarded $349,952 on June 20, 2025, for a one-year R41TR005379 project covering viability, cytotoxicity and intestinal-fibrosis validation. A second listing reports $1,046,897 for a Phase II project running July 1, 2026, through June 30, 2028, focused on production scale-up, quality control, shelf-life, cryopreservation and high-throughput toxicity and fibrosis assays.
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The 2025 grant abstract says that “90% of new drugs fail clinical trials.” That figure is presented in the grant context and should not be treated as a universally established industry statistic. It does, however, explain why funders are supporting methods intended to improve early human-relevance testing.
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Intero’s July 2025 announcement characterizes FDA and NIH initiatives as increasing attention to organoids, microphysiological systems and other NAMs. That is the company’s description of policy direction; whether a particular regulator accepts GastroScreen data depends on the study design, validation package and submission.
What prospective users should verify
- Which organoid batch, storage condition and viability specification will be used.
- Whether the planned endpoint is supported: barrier integrity, cytotoxicity, inflammation, fibrosis, motility, vascular response or neuromuscular activity.
- How Intero controls batch-to-batch variability and confirms the included cell types and functions.
- Whether live or frozen shipments fit the laboratory’s equipment, timing and biosafety workflow.
- What positive and negative controls are included, especially compounds with known human intestinal effects.
- How the resulting data will be compared with existing animal, clinical or historical reference data for a regulatory decision.
Intero offers custom experiments and analysis for customers that do not want to establish the entire workflow themselves. Pricing, turnaround times and regulatory acceptance are not established by the information available here and require a direct quote and method-specific discussion.
What this means for animal testing
GastroScreen represents a practical attempt to put more human intestinal biology into preclinical screening: multiple cell types, a barrier, vessels, nerves and movement in one testable system. Its live and frozen formats, assay compatibility and custom-study option make it usable by professional research laboratories today. The central unanswered question is predictive performance at scale. Intero’s ongoing comparisons with animal and clinical outcomes will determine whether the platform becomes an accepted replacement for some tests, a complement to them, or both in different stages of drug development.
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