By Sara Reardon
The US Food and Drug Administration (FDA) has started testing whether livers-on-a-chip — miniature models of human organs engineered to mimic biological functions — can reliably model human reactions to food and food-borne illnesses. The experiments will help the agency to determine whether companies can substitute chip data for animal data when applying for the approval of a new compound, such as a food additive, that could prove toxic. It is the first time that a regulatory agency anywhere in the world has pursued organs-on-chips as an alternative to animal testing.
Suzanne Fitzpatrick, senior adviser for toxicology in the food-safety division of the FDA, announced the move on 11 April in a blog post. Although the chips were designed for testing drugs, Fitzpatrick’s division wants to use them to see how individual organs process products such as dietary supplements and cosmetics. They will also be able to test how food-borne pathogens affect specific organs. FDA food-safety scientists will first evaluate the human-liver chip, before moving on to kidney, lung and intestine models.
The chips are made by Emulate, a biotechnology company in Boston, Massachusetts. The miniature organs contain multiple types of human liver cells grown on a scaffold, and continuously pump a blood-like fluid through the system to deliver nutrients and remove waste. Emulate chief executive Geraldine Hamilton says that they can also add immune system components to the chip to test how it affects liver metabolism.
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