Methods and kits for ascertaining biosafety of an agent

Abstract

A method of ascertaining the bio-safety of an agent is disclosed. The method comprises: (a) contacting the agent with differentiating human pluripotent stem cells; (b) analyzing a level of gene expression of a plurality of genes in the differentiating human pluripotent stem cells, wherein the agent is qualified as being safe if at least one of the following qualification parameters are fulfilled: (i) the agent causes a difference in the level of gene expression below a predetermined number of genes as compared to control differentiating human pluripotent stem cells that have not been contacted with the agent; (ii) the agent causes a difference in gene expression below a predetermined number of tissue-specific genes of a tissue as compared to control differentiating human pluripotent stem cells that have not been contacted with the agent; or (iii) the agent causes a difference in gene expression below a predetermined number of genes involved in fetal development as compared to control differentiating human pluripotent stem cells that have not been contacted with the agent.

Dependencies are inferred from the claim text.