BOSTON — September 9, 2026
Emulate, Inc. announced the submission of its FDA Innovative Science and Technology Approaches for New Drugs (ISTAND) Full Qualification Package (FQP) for its Human Liver-Chip, marking a major step toward establishing Organ-on-a-Chip technology as a qualified Drug Development Tool (DDT) for drug-induced liver injury (DILI) assessment. The qualification package includes data generated using both Emulate’s Zoë® Culture Module and next-generation AVA™ Emulation System, extending the regulatory evidence across two Organ-Chip platforms designed for different pharmaceutical research scales. If ultimately qualified by the FDA, the Human Liver-Chip could provide drug developers with a standardized, human-relevant approach to evaluating liver toxicity while establishing an important regulatory precedent for Organ-on-a-Chip technology. The submission follows years of scientific and regulatory collaboration between Emulate and the FDA and represents the company’s latest effort to move human-relevant preclinical testing closer to routine drug development workflows.
Human Liver-Chip Demonstrates Reproducible DILI Performance
The qualification package is supported by data demonstrating reproducibility, biological robustness and consistent assay performance across multiple experimental settings. Studies were conducted at three independent laboratories using primary human hepatocytes from three different donors, with results demonstrating consistent performance as a biological testing tool. The Human Liver-Chip also showed an ability to distinguish between structurally similar compounds that have different liver toxicity profiles, an important capability for evaluating potential DILI risk during drug development. Repeat studies conducted months apart generated consistent results, providing additional evidence of assay reliability over time. Together, these findings address key characteristics needed for broader adoption of a new Drug Development Tool, including reproducibility across laboratories, biological sources and study periods. Emulate said the evidence package has been shaped by FDA feedback and scientific questions throughout the earlier Letter of Intent and Qualification Plan stages, strengthening the company’s regulatory strategy as it seeks formal qualification.
AVA Extends Liver-Chip Technology to Higher Throughput
The inclusion of data from the AVA Emulation System represents a significant expansion of the qualification package, demonstrating that the Human Liver-Chip’s scientific performance can be translated from the established Zoë platform to an automated, higher-throughput environment. The AVA system is designed to support pharmaceutical research at larger scale, with capacity for up to 96 independent Organ-Chip samples per run. This scalability could be particularly important for drug discovery and development organizations that require greater experimental throughput while maintaining human-relevant biological models. Emulate said incorporating both platforms could allow researchers to progress from Zoë-based studies to AVA as their throughput requirements increase, potentially supporting a more continuous Organ-Chip workflow across different stages of pharmaceutical research. The company views the ability to maintain consistent performance across platforms as an important factor in moving Organ-on-a-Chip technology beyond specialized research applications and toward broader integration into standard preclinical development processes.
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Emulate Targets Regulatory Adoption of Organ-on-a-Chip
The FDA ISTAND submission positions Emulate at the intersection of regulatory science, human-relevant testing and next-generation drug development technology as the company works toward broader acceptance of Organ-on-a-Chip models. Emulate’s Human Liver-Chip program has been developed through ongoing collaboration with the FDA, including scientific publications intended to establish best practices for generating and interpreting Liver-Chip data. Formal qualification could give pharmaceutical developers a clearer regulatory pathway for using the technology in DILI assessment, potentially strengthening confidence in human-relevant alternatives to conventional preclinical approaches. The company also sees the technology as part of a broader effort to improve drug-development decision-making, reduce reliance on animal testing and generate data that more closely reflects human biology. The final-stage ISTAND submission, supported by evidence from both Zoë and AVA, represents a key regulatory and commercial milestone for Emulate and could help determine whether Organ-on-a-Chip technology can move into more standardized pharmaceutical research and development workflows.
Source: Emulate, Emulate Inc, press release
