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HepatoSIGHT:A non-animal new approach methodology to test predict human hepatotoxicity like safety concerns

Cell type used as testing platform
TRANS-MSC: Characterized Configured Human induced Pluripotent Stem Cells (HiPSC) type of adult primary and progenitors
Insilico platform used to publish the report
HepatoSIGHT software (trained on Convolutional Neural Network)
Assay endpoints:
Human hepatocytes exhibit high metabolic activity, they contain high levels of intracellular ATP (iATP), which is used to monitor functional viability and, therefore, potential cytotoxicity
Drug Induced Liver Injury (DILI)-Sandwich method
Dose-dependent, intrinsic, DILI can be detected and measured. The following are the readouts of HepatoSIGHT assay system:

  • Mitochondrial functional impairment – Copy number, mitochondrial membrane potential
  • Initiation of apoptosis/Necrosis – Staining with annexin5/RT PCR analysis
  • Alteration of protein function – enzymes or transporters
  • Alterations of redox status – SOD status
  • Activation of immune or inflammatory response – These factors can be measured for IL-2, IL-31, IL-17A etc

Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs). Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. PMID: 32325112.

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