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AI Biotech Owkin has received a letter of support from the European Medicines Agency (EMA) for their proposed statistical adjustment on deep learning prognosis covariates obtained from histological slides. The proposed method uses the predictions of two deep-learning models, MesoNet and HCCnet, as prognostic biomarkers for the adjustment of efficacy analysis on the overall survival of life-prolonging drugs in randomized phase 2 and phase 3 clinical trials. The models brought a significant improvement in prognostic performance for overall survival when added to currently used stratification factors.
