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Drug-induced liver injury (DILI) is a challenging disease to diagnose, a leading cause of acute liver failure, and responsible for drug withdrawal from the market. There is no symptom, no biomarker or test for detection, no therapy, but discontinuation of the drug. Pharmaceutical companies spend huge money, time, and scientific research efforts to test DILI effects and drug efficacy. A preclinical diagnostic support system is designed and proposed for DILI detection and classification on liver biopsy histopathology images. Heterogeneity features and automated machine learning (AutoML) models were tested to classify DILI injury patterns on whole slide image. Fractal and lacunarity values were used to detect hepatocellular necrotic injury patterns caused on a rat liver ( in vivo ) by 10 drugs at four dose levels. Correlations between fractal and lacunarity values were statistically analyzed for the 10 drugs; the Pearson correlation ( r  = 0.9809), p -value (1.6612E-06), and R  2 (0.9582) were found to be high in the case of carbon tetrachloride. The AutoML model was tested to understand the injury patterns on a subset of 1,277 histology images. The AutoML algorithm was able to classify necrotic injury patterns accurately with an average precision of 98.6% on a score threshold of 0.5 .

assay and drug development technologies

Automated Machine Learning Diagnostic Support System as a Computational Biomarker for Detecting Drug-Induced Liver Injury Patterns in Whole Slide Liver Pathology Images