FDA Collaborates with Emulate to Use Organs-on-Chips Technology as a Toxicology Testing Platform

Emulate has entered into a cooperative research and development agreement (CRADA) with the FDA to evaluate and qualify the use of Emulate’s Organs-on-Chips technology as a platform for toxicology testing to meet regulatory evaluation criteria for products.

The CRADA studies will use Emulate’s human emulation system, comprised of Organ-Chips, instrumentation and software apps. The system recreates the natural physiology of specific human tissues and organs, and is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods with greater precision and detail than other preclinical testing methods, such as cell culture or animal-based experimental testing.

The collaborative studies under the CRADA will use various liver-chips in an applied toxicology setting to assess the system’s capabilities to predict the effects on human biology of chemical and microbiological hazards found in foods, cosmetics and dietary supplements.

The agreement allows for future expansion to additional Organ-Chips, including the intestine-chip, lung-chip and cardiac systems. — Cynthia Jessup