The small plastic chip etched with channels is a synthetic human organ—and one vision of future drug safety testing. Inside, layers of human liver, epithelial, and immune cells line the tiny conduits, which feed them with bloodlike fluid and remove waste. The chip, made by the Boston-based biotech company Emulate Inc., could one day help researchers and pharmaceutical companies screen out candidate drugs that cause a condition known as drug-induced liver injury (DILI)—one of several types of liver toxicity that together scuttle 22% of all clinical trials.
DILI often doesn’t show up when drugs are tested in animals. But in a recent study, Emulate’s chip was 87% accurate in identifying compounds known to cause DILI—and 100% accurate in flagging those that don’t. The chip is now undergoing further testing as part of a new U.S. Food and Drug Administration (FDA) pilot program to evaluate alternatives to animal testing. If it performs well, drug developers will be able to use data it generates to show a new drug is likely safe before they apply to begin human trials.
Animal rights activists see organ chips and similar technologies as a potential means to replace the tens of millions of lab animals used annually in the United States to test the safety of drugs, foods, and chemicals and to do basic research. And, increasingly, U.S. agencies seem to agree. In April, both FDA and the Environmental Protection Agency (EPA) announced they plan to move away from requiring animal tests for certain drug candidates and chemicals such as pesticides. Both agencies will now encourage—but not yet require— researchers to use organ chips and other new approach methodologies (NAMs) to determine whether a drug is safe enough for human testing or a new chemical can be safely marketed. In July, the National Institutes of Health (NIH) followed suit, announcing it would
More: https://www.science.org/content/article/u-s-wants-phase-out-animal-research-are-alternatives-ready
