Patent ID: 7198895

Claim:
A method of predicting a patient's in vivo response to a chemical entity, comprising: (i) creating a set of reference cellular responses, wherein the cellular responses are selected from the group consisting of gene expression, increased motility, chemotaxis, contraction, relaxation, biosynthesis, secretion of signaling molecules, depolarization, repolarization, degranulation, adhesion, aggregation, change in metabolic rate, and immediate cellular responses, to the chemical entity, wherein the chemical entity is selected from the group consisting of a registered chemical entity, a novel chemical entity, an environmental reagent, and a biological in peripheral blood mononuclear cells, wherein peripheral blood mononuclear cells are selected from the group consisting of T-lymphocytes, B-lymphocytes, monocytes, natural killer cells, and peripheral blood stem cells, which cellular responses are correlated with in vivo responses in a population of subjects; (ii) drawing said peripheral blood mononuclear cells from the patient; (iii) detecting the cellular response of the patient's peripheral blood mononuclear cells to the chemical entity, wherein step (iii) comprises: (a) transducing the patient's peripheral blood mononuclear cells with a zinc finger protein that specifically expresses or upregulates the target for the chemical entity; (b) exposing the transduced peripheral blood mononuclear cells to the chemical entity and (c) detecting resultant cellular responses of the patient's peripheral blood mononuclear cells' to the chemical entity; (iv) identifying the cellular response in the reference set of step (i) that corresponds to the patient's cellular response of step (iii); and (v) determining the in vivo response which correlates with the cellular response in the reference set identified in step (iv); wherein the patient is predicted to have the in vivo response determined in step (v) when exposed to the chemical entity in vivo.