CardioSIGHT A non-animal new approach methodology to test predict human cardiotoxicity 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
CardioSIGHT software (trained on Convolutional Neural Network)
Cardiotoxicity I
Phenotype changes
Cardiotoxicity II
Rhythm disturbance
CCK8 assay/WST 8
Cell viability status
Functional gene expression changes
Transcription changes
Mitochondrial toxicity
Mitochondrial metabolism
K assay
Potassium channel activity
Ca assay
Calcium flux determination
MEA assay
Action potential measurement
Reference:
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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