Advancing The Human Liver-Chip Toward FDA Qualification: A New Era For DILI Prediction

Drug-induced liver injury remains a persistent challenge because conventional preclinical models cannot always capture the human-specific biology behind liver responses. Emulate’s Human Liver-Chip offers a more predictive approach, achieving 87% sensitivity and 100% specificity across 27 small molecule drugs with known clinical outcomes, including compounds whose risks were not reliably identified through animal testing. Following the August 2026 submission of a Full Qualification Package to the FDA’s ISTAND program, the technology has entered the final stage of qualification as a Drug Development Tool for DILI assessment. Daniel Levner, Ph.D., explains the evidence supporting the Liver-Chip, its role alongside existing safety methods, and the potential impact of FDA qualification.

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