ProDigest Awarded FDA Contract to Provide a Preclinical Gastrointestinal Model: SHIME®

ProDigest has been awarded a contract to provide a SHIME® (Simulator of Human Intestinal Microbial Ecosystem) technology platform for full gut simulation to the US Food and Drug Administration (FDA), National Center for Toxicological Research.

The SHIME® model is currently the most representative validated in vitro technology for the combined simulation of the physiological, chemical and microbiological properties of the full gastrointestinal tract. The model enables study of the impact of long-term repeated dosing and of the modulation of the microbiota in function of the gut location. The SHIME® can be seen as a clinical trial in vitro, which can provide the spatio-temporal insight into the mechanism of action of a specific treatment, therefore providing compelementary data to in vivo studies.

“This is another important milestone in the history of ProDigest showing the value that our technology platforms can have for private and public sector”,

stated Massimo Marzorati, CEO of ProDigest.

SHIME® is characterized by a high flexibility to adapt to multiple experimental designs, to best fit specific research questions (i.e. TwinSHIME®; TripleSHIME®; QuadSHIME®; ScreeningSHIME®).

“Together with the Colon-on-a-plate® (a high-throughput colonic simulation), MetaKey® (a unique metabolomic platform) and multiple cell models, we are able to provide the broadest offering on the market in terms of in vitro/ex vivo gut simulation to support our clients with the best scientific answers to their research questions”

concluded Massimo Marzorati.

About ProDigest

ProDigest is a product leader in the development of unique laboratory models of the human and animal gastrointestinal tract (SHIME®; Colon-on-a-plate®). These models allow to obtain unique insight in gut processes associated to the intestinal fate of actives and its link with host’s health. ProDigest is globally active as a service provider for food and pharmaceutical companies and since 2014 also installs its technology in selected R&D facilities around the world. In 2021, ProDigest launched a new business unit, MetaKey®, for integrated metabolomics services.