CN Bio, a leading provider of Organ-on-a-chip (OOC) Systems and solutions that accelerate drug discovery and development workflows, today announced the launch of its PhysioMimix^® DILI assay kit: Human 24. Built upon CN Bio’s human-derived and highly characterized liver microphysiological system (MPS), the DILI assay kit provides robust, human-relevant insights into crucial drug safety parameters, to support more informed clinical progression of drug candidates, enhanced clinical preparedness, and help de-risk drug development workflows by ensuring only the most promising therapeutic candidates are selected.

Even today, 30% of drug candidates fail in clinical trials, and 18% of these failures are attributed to hepatotoxicity concerns¹. Existing methods to assess human drug-induced liver injury (DILI) use a combination of data sources, including in vitro assays, in vivo animal studies, and in silico modelling. Current preclinical approaches are limited by sensitivity, clinical translatability, and physiological relevance. CN Bio’s FDA-recognized liver MPS has been designed to overcome these limitations, providing robust, human-specific data to accurately inform drug-induced hepatotoxicity².

Initially launched as part of the Company’s contract research services (CRS)³, CN Bio’s human DILI assay has been further refined into an all-in-one kit to optimize preclinical drug development by providing deeper, physiologically relevant, mechanistic hepatotoxicity insights. The kit streamlines workflows by removing the challenges associated with MPS model development and validation, allowing new users to rapidly integrate the OOC solution into their own labs.

CN Bio’s liver model recreates highly functional and metabolically active hepatic tissues. It can be maintained under perfusion for up to two weeks and incorporates Kupffer cells to capture crucial aspects of the human innate immune system, facilitating deeper insights into the most complex toxicology events over extended timeframes. As the kit leverages primary human tissue, it also better supports the development of new, human-specific drug modalities, an area for which traditional preclinical tools often lack the relevant targets or pathways.

Every DILI assay kit provides 24 wells, allowing users to simultaneously assess up to eight conditions in triplicate. This breadth of data output, covering key DILI pathways, means that customers can easily screen a selection of drug candidates, supporting earlier identification of flawed molecules, improving efficiency and reducing cost.

Dr Ovidiu Novac, Senior Scientist and Project Manager (DILI assay kit), CN Bio, said: “Toxicology testing is perhaps the most essential part of developing a new drug, but our current preclinical methods often fall short, putting therapeutic developers at risk of extremely costly, late-stage failures. Previously available via our CRS, we chose to further develop our DILI assay into a simple, all-in-one kit, in response to increasing demand for human-relevant, preclinical toxicology testing. With Human 24, PhysioMimix users can now more easily replicate our industry-leading DILI assay in their own lab, providing deeper mechanistic insights into drug-induced hepatoxicity and enabling more confident progression of drug candidates into the clinic.”

1. Walker PA, Ryder S, Lavado A, Dilworth Clive, Riley RJ. The evolution of strategies to minimise the risk of human drug-induced liver injury (DILI) in drug discovery and development. Arch Toxicol. 2020;94:2559-2585. doi:10.1007/s00204-020-02763-w
2. Rubiano A, Amruta Indapurkar |, Yokosawa R, et al. Characterizing the reproducibility in using a liver microphysiological system for assaying drug toxicity, metabolism, and accumulation. Clin Transl Sci. 2021;14. doi:10.1111/cts.12969
3. Press Release (27 October 2020): Extended range of services supports accelerated drug discovery and development using predictive 3D Liver-on-Chip technology

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