Could organs on a microchip help test for toxins? The FDA wants to find out
- Privately held tech company Emulate, Inc., which has engineered so-called "organs on chips," announced April 11 it had signed a collaborative agreement with the Food and Drug Administration to develop its Human Emulation System as a toxicology testing platform.
- The multi-year Cooperative Research and Development Agreement (CRADA) will assess whether Emulate's Liver-Chips, instrumentation and software apps meet regulatory evaluation criteria as a test for chemical and microbiological hazards in products ranging from food and dietary supplements to cosmetics.
- Under the agreement, the collaboration could eventually expand to other Organ-Chips, including Emulate's Intestine-Chip, Lung-Chip, and Cardiac systems. Drug products are currently not covered by the deal.
Last March, Emulate announced it had raised $28 million in Series B funding to continue development of its organ-on-a-chip technology, which simulates human organs by lining micro-engineered chips with human cells.
Emulate claims the system effectively recreates the natural physiology of human tissue and human organs, such as the liver, lungs or intestines.
Technologies like Emulate's may eventually have a future in drug development by creating in vitro assay systems that more closely mimic human biology than cell lines or animal models. If effectively validated, this could speed development through early preclinical stages since a model of human tissue would theoretically be more predictive than other testing methods.
Such a platform might also reduce the number of animals used in early testing.
The agreement with the FDA is one step towards that goal, albeit in non-therapeutic products. Emulate is allowed to use information obtained through its work with the FDA to further development of its Human Emulation System.
For now, the deal focuses on Emulate's Liver-Chip and will evaluate its capacity to assess health effects of chemical and microbiological contaminants in food, dietary supplements, and cosmetic products.
"They can be put to work to see how the body processes an ingredient in a dietary supplement or a chemical in a cosmetic and how a toxin or combination of toxins affects cells, information that ultimately can be used to help assess risks to human health," explained Suzanne Fitzpatrick, senior advisor for toxicology at the FDA’s Center for Food Safety and Applied Nutrition, in a blog post.
- Emulate Press release
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