Emulate Submits Full Qualification Package to FDA ISTAND Program for Human Liver-Chip DILI Assessment
核心洞察
Emulate has submitted its FDA ISTAND full qualification package for the Human Liver-Chip (搜索), seeking qualification as a Drug Development Tool for drug-induced liver injury (搜索) assessment.
The submission covers both the Zoë Culture Module and the next-generation AVA Emulation System, marking the first time AVA data enters the FDA qualification process.
Package data show reproducibility across three independent laboratories and three primary human hepatocyte donors, plus consistent discrimination of structurally similar compounds with differing liver toxicity.
Emulate, Inc. (搜索) announced on September 9, 2026 that it has submitted its FDA Innovative Science and Technology Approaches for New Drugs (ISTAND) full qualification package (FQP) for its Human Liver-Chip (搜索), moving the Organ-on-a-Chip platform into the final stage of the agency's qualification process. The submission seeks to establish the Liver-Chip as a qualified Drug Development Tool (DDT) for drug-induced liver injury (搜索) (DILI) assessment.
The package includes data generated on both Emulate's Zoë Culture Module and its next-generation AVA Emulation System, extending the qualification across two Organ-Chip platforms designed to support different stages and scales of pharmaceutical research. It is the first time data from the AVA Emulation System will be evaluated as part of the FDA qualification process.
If the FDA qualifies the Human Liver-Chip (搜索) for DILI assessment, it would establish a regulatory precedent for Organ-on-a-Chip technology and give drug developers a standardized, human-relevant approach for evaluating liver toxicity, according to the company.
Evidence Package and Reproducibility Data
Emulate said the qualification package includes data demonstrating reproducibility across three independent laboratories using three different primary human hepatocyte donors, supporting the platform's robustness as a biological tool. The data also show a consistent ability to distinguish between structurally similar compounds with different liver toxicity profiles, and reliable performance over time, with repeat studies conducted months apart producing consistent results.
The submission also documents successful translation of the assay to the high-throughput AVA Emulation System, which supports up to 96 independent Organ-Chip samples per run for pharmaceutical research. While the initial round of qualification data was established on the Zoë platform, incorporating AVA data in the final submission demonstrates that the same scientific performance can be achieved on the automated, higher-throughput system. Including both platforms in the package would allow researchers to move from Zoë to AVA as throughput needs grow.
"The strength of this submission is not simply that the Liver-Chip works, it's that it works consistently," said Lorna Ewart, Ph.D., Emulate's Chief Scientific Officer. "The data show reproducibility across laboratories, multiple cell donors, and studies conducted months apart, which are exactly the characteristics regulators and industry need to trust a new Drug Development Tool. Including AVA in the qualification package also extends that confidence to a platform designed for larger-scale studies, making it a realistic tool to incorporate in standard pharmaceutical workflows."
Regulatory Path and FDA Collaboration
Emulate said its application was strengthened and shaped by FDA reviewers' comments and questions throughout the Letter of Intent and Qualification Plan stages of the ISTAND process.
"Submitting this qualification package represents years of close collaboration with the FDA and reflects the maturity of Organ-on-a-Chip technology as a practical tool for drug development," said Jim Corbett, Chief Executive Officer of Emulate. "Our application has been strengthened and shaped by the FDA reviewers' comments and questions throughout the Letter of Intent and Qualification Plan stages, helping us develop a robust evidence package to support qualification."
The qualification package was spearheaded by Emulate's Chief Technology Officer Daniel Levner, Ph.D., and Chief Scientific Officer Lorna Ewart, Ph.D. The submission builds on years of collaboration between Emulate and the FDA, including joint scientific publications that helped establish best practices and official guidelines for interpreting Liver-Chip data.
Emulate framed entry into the final stage of the ISTAND qualification process as part of the FDA's broader efforts to accelerate adoption of scientifically validated, human-relevant methods to improve drug development and reduce reliance on animal testing.